HIPAA Compliance for Medical Practices
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HIPAA Compliance for Medical Practices
HIPAA Compliance and HIPAA Risk management Articles, Tips and Updates for Medical Practices and Physicians
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The HIPAA Password Requirements

The HIPAA Password Requirements | HIPAA Compliance for Medical Practices | Scoop.it

The HIPAA password requirements stipulate procedures must be put in place for creating, changing and safeguarding passwords unless an alternative, equally-effective security measure is implemented. We suggest the best way to comply with the HIPAA password requirements is with two factor authentication.

 

The HIPAA password requirements can be found in the Administrative Safeguards of the HIPAA Security Rule. Under the section relating to Security Awareness and Training, §164.308(a)(5) stipulates Covered Entities must implement “procedures for creating, changing and safeguarding passwords”.

Experts Disagree on Best HIPAA Compliance Password Policy

Although all security experts agree the need for a strong password (the longest possible, including numbers, special characters, and a mixture of upper and lower case letters), many disagree on the best HIPAA compliance password policy, the frequency at which passwords should be changed (if at all) and the best way of safeguarding them.

 

Whereas some experts claim the best HIPAA compliance password policy involves changing passwords every sixty or ninety days, other experts say the effort is a waste of time. A competent hacker should be able to crack any user-generated password within ten minutes using a combination of technical, sociological, or subversive methods (i.e. social engineering).

 

There is more agreement between experts when it comes to safeguarding passwords. In respect of a best practice for a HIPAA compliance password policy, a large majority recommend the use of password management tools. Although these tools can also be hacked, the software saves passwords in encrypted format, making them unusable by hackers.

The HIPAA Password Requirements are Addressable Requirements

One important point to mention when discussing the HIPAA password requirements is that they are “addressable” requirements. This does not mean they can be put off to another date. It means Covered Entities can “implement one or more alternative security measures to accomplish the same purpose.”

In the context of the Administrative Safeguards, the purpose of the HIPAA password requirements is to “limit unnecessary or inappropriate access to and disclosure of Protected Health Information”. Therefore, if an alternative security measure can be implemented that accomplishes the same purpose as creating, changing and safeguarding passwords, the Covered Entity is in compliance with HIPAA.

 

Two-factor authentication fulfills this requirement perfectly. Whether by SMS notification or push notification, a person using a username and password to log into a database containing PHI also has to insert a PIN code to confirm their identity. As a unique PIN code is issued with each log in attempt, a compromised password alone will not give a hacker access to the secure database.

Two Factor Authentication is Already Used by Many Medical Facilities

Interestingly, two factor authentication is already used by many medical facilities, but not to safeguard the confidentiality, integrity and security of PHI. Instead it is used by medical facilities accepting credit card payments to comply with the Payment Card Industry Data Security Standard (PCI DSS) and by others to comply with the DEA´s Electronic Prescription for Controlled Substances Rules.

 

Healthcare IT professionals will be quick to stress that two factor authentication can slow workflows, but recent advances in the software allow for LDAP integration and Single Sign-On between healthcare technologies. As two factor authentication software only transmits PIN codes (and not PHI) the software does not need to be HIPAA compliant, and it is a far easier solution for compliance with the HIPAA Password requirements than frequent changes of passwords and password management tools.

 

Effectively, Covered Entities never need change a password again.

The only thing Covered Entities have to remember before implementing two factor authentication to protect PHI is that, because the HIPAA Password requirements are addressable safeguards, the reasons for implementing the alternative solution have to be documented. This will satisfy the HIPAA requirements for conducting a risk analysis and also satisfy auditors if the Covered Entity is chosen to be investigated as part of HHS´ HIPAA Audit Program.

Why an Alternative to the HIPAA Password Requirements should be Considered

It was mentioned above that most user-generated passwords can be cracked within ten minutes. That may seem an outrageous claim to some IT professionals, but this tool on the ramdom-ize password generating website will give you an idea of how long it could take a determined hacker to crack any password by brute force alone. Social engineering and phishing will likely accelerate the speed at which the hacker succeeds.

 

Randomized passwords containing numbers, symbols and a mixture of upper and lower case letters obviously take a longer to crack – but they are still crackable. They are also much harder for users to remember; and although secure password management tools exist to store passwords securely, if a user wants to access a password-protected account from another device, password management tools are ineffective. The only way for the user to access the account is to have the password written down or saved on another device – such as an unsecured smartphone.

 

Accessing password-protected accounts from secondary devices increases the risk of a data breach due to keylogging malware. This type of malware runs undetected on computers and mobile devices, secretly recording every keystroke in a file for later retrieval by a hacker. As this is a foreseeable risk to the security of Protected Health Information, Covered Entities must either introduce policies to limit users to the devices from which they can access password-protected accounts, or find an alternative to the HIPAA password requirements.  

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HIPAA Regulations for Radiologists 101

HIPAA Regulations for Radiologists 101 | HIPAA Compliance for Medical Practices | Scoop.it

HIPAA regulations are a complex set of rules and regulations that are designed to promote a more patient oriented medical system that enhances patient care. HIPAA regulations that promote the accessibility of medical records to patients and increase the security of electronic patient health information are also included in the HIPAA Omnibus Rule. Radiologists often receive patients through a referral system or send patient files to another medical doctor or facility after x-rays and other scans are interpreted. This constant sharing of sensitive patient information makes learning what are HIPAA regulations and how do they affect radiologists an important task for any radiologist.

 

HIPAA Omnibus Rule

The HIPAA Omnibus Rule has changed the way that patient information is collected, stored, transmitted and created in response to the HITECH Act. The HITECH Act offers organizations incentives for using electronic patient health information while improving the security of that data. When asking what are HIPAA regulations one of the most important things to consider is your organization’s privacy policy. New HIPAA regulations state that organizations and entities must update their privacy policies and business agreements to comply with the current standards.

 

Current HIPAA standards require that all businesses sharing patient information must be HIPAA compliant. For instance, if a radiologist receives referrals or bills insurance companies on behalf of clients, the insurance company and the organization referring clients should both be HIPAA compliant. Current business associate agreements will be allowed until late September of 2014, but after that date all business associates will need to comply with the HIPAA Security Rule to avoid penalties or fines.

 

What is Affected by HIPAA?

Nearly every aspect of creating, sharing and transmitting electronic patient health information has been affected by new HIPAA regulations. In addition to revising and updating your organization’s privacy policies and business agreements, you will also need to look at your internal records storage and the accessibility of patient records. For instance, your internal computer systems must be secure and protected from data loss or third-party access. Data encryption is required anytime that you transmit electronic patient information. If your organization is using a third-party storage system for patient health information, the company providing web-based storage services will also need to be HIPAA compliant.

 

One of the areas that will be most affected for radiologists is how patient information is disclosed. Since radiology is a field where referrals are very common, care must be taken to ensure formal, written consent is provided each time you share patient health information. For example, a radiologist sending the results of an x-ray to a general practitioner will need to have written consent by the patient to do so. In order to understand and comply with current HIPAA regulations, it is best to use a HIPAA compliance checklist and HIPAA compliance software. HIPAA compliance software will walk you through the process of meeting current HIPAA regulations and help you avoid the confusion of updating and revising your current policies and practices on your own.
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Why Ignoring the Minimum Necessary Standard in HIPAA Could Cost You

Why Ignoring the Minimum Necessary Standard in HIPAA Could Cost You | HIPAA Compliance for Medical Practices | Scoop.it

Does your healthcare organization develop and implement policies and procedures that are appropriate and reflect your organization’s business practices?

Under the HIPAA Minimum Necessary Standard, all covered entities must have policies and procedures that identify who needs access to Protected Health Information (PHI) to perform their job duties, the categories of PHI required, and the conditions where access is justified.

 

For instance, as a hospital, you can allow doctors, surgeons, or others to access a patient’s medical records if they’re involved in the treatment of that patient. If the entire medical history is required, your organization’s policies and procedures must explicitly state so and include a justified reason.

 

As a provider, you also need to take reasonable steps to make sure that no PHI is accidentally available for access. For example, if you’ll be hosting a meeting in your office, then you must ensure that no one from the meeting can access PHI documents accidentally.

How Does The Minimum  Necessary Requirement Work?

As the name implies, under the HIPAA Minimum Necessary Standard, it’s mandatory for covered entities to take reasonable measures to limit the use or disclosure of PHI and requests for PHI, to the minimum necessary needed to achieve the intended goal.

However, it’s important to note that the minimum necessary standard does not apply to:

  • Requests for disclosure by a healthcare provider for treatment purposes  
  • Disclosing information to the patient in question   
  • Uses or disclosures after a patient’s authorization  
  • Uses or disclosures needed to comply with the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification Rules  
  • Disclosing PHI to the Department of Health and Human Services (HHS) under the Privacy Rule for reasons of enforcement  
  • Disclosing PHI for use under other laws

The Minimum Necessary Standard of the HIPAA Privacy Rule requires that your covered entity develops and implements policies and procedures that are appropriate for your organization and that reflect your business’ practices and workforce. Only those who need access to PHI should receive access, and even then, the PHI should be restricted to the minimum necessary information needed to perform the job.

Why Does It Matter?

Did you know the healthcare industry is one of the most vulnerable sectors when it comes to cyber-attacks and data theft? If your organization fails to meet the minimum necessary standard, you could face fines of $50,000 or more.     

 

In fact, penalties for HIPAA violations can reach $1,500,000 annually per violation based on the type of breach.  

The largest American health data breach to ever occur took place in January 2015. It exposed the electronic PHI of nearly 79 million people and resulted in Anthem Insurance paying OCR $16 Million!  

The investigation found that Anthem did not perform

enterprise-wide risk analysis and the organization’s procedures did not regularly review information system activity. Anthem also failed to identify and respond to security incidents, and they did not implement proper minimum access controls to prevent the risk of cyber-attacks from stealing sensitive ePHI.

 

Complying with HIPAA’s minimum necessary standard matters if you want to avoid the risk of an expensive fine.

How Can You Comply?

Under HIPAA’s minimum necessary standard, the terms ‘reasonable’ and ‘necessary’ are open to interpretation and left up to the judgment of the covered entity. It’s up to your organization to determine what information should be disclosed and what information needs restricted access.

 

However, to make sure that you’re complying with this requirement, there are some basic steps you should follow:

  1. Prepare a list of all systems that contain PHI and what types of PHI they include.
  2. Establish role-based permissions that restrict access to certain kinds of PHI. All information systems should limit access to certain types of information. For instance, you can limit access to health insurance numbers, Social Security numbers, and medical histories if it’s not necessary for everyone to see that PHI.
  3. Design and implement a policy for sanctions if violations of the minimum necessary standard occur.
  4. Provide proper employee training about the types of information they’re permitted to access and what information is off limits. Be clear about the consequences of obtaining information when not authorized.
  5. Create alerts when possible that notify the compliance team if there’s an unauthorized attempt to access PHI.
  6. Ensure that the minimum necessary rule is being applied to all information shared externally, with third parties and subcontractors. It’s mandatory for covered entities to limit how much PHI is disclosed based on the job duties and the nature of the third party’s business.
  7. Perform annual reviews and periodic audits of permissions and review logs to determine if anyone has knowingly or unknowingly accessed restricted information. Such reviews may also be required when a major incident takes place, such as the treatment of a celebrity in your organization, or if a shooting or newsworthy accident takes place and your organization is involved.
  8. Document all actions taken to address cases of unauthorized access or accessing more information than is necessary and the sanctions that took place as a result.

Adhering to the HIPAA Minimum Necessary Standard is important to protect your organization and your patient relationships. When you take the appropriate steps to comply with HIPAA, you’ll not only have a much better chance of avoiding the risk of a costly data breach, but you’ll also build trust with your patients.

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How HIPAA Helps Strengthen Patient Trust

How HIPAA Helps Strengthen Patient Trust | HIPAA Compliance for Medical Practices | Scoop.it

Trust is a vital factor that affects the success of any relationship, whether it be personal or professional. Without this foundational element, interpersonal and business relationships would be filled with suspicion and uncertainty leading to conflict and ultimately the disintegration of any bond that existed.

 

In today’s digitally-driven world, this core human value is now more critical than ever. Many of the transactions we perform daily force us to deal with entities we have never met in real life. Dealing with any organization that processes and stores our personal data requires us to trust that they will honor their commitments and keep our sensitive information secure.

 

When it comes to healthcare, patient trust is a core element of any practice. Any incident that jeopardizes patient trust can destroy the relationship and threaten the future of the organization.  As people are effectively placing their health and welfare under the direct care of a practitioner, trust is effectively the only human emotion at play in this relationship.

 

We not only trust them with our lives but with keeping our medical information private and secure. Should this data be compromised in any way, it would not only place the patient in a precarious position but would also destroy the trust relationship that existed with the practitioner.

HIPAA Strengthens Patient Trust

The Health Insurance Portability and Accountability Act (HIPAA) helps strengthen patient trust in various ways. It provides mechanisms that enhance the transparency, privacy, and security of electronic healthcare information. Not only does the Act help prevent sensitive patient data from compromise, but it also gives patients access and protects their private medical information.

 

Under HIPAA, medical organizations and practitioners that process and store patient healthcare information must implement measures that ensure compliance with the obligations stipulated under the statute.

 

Some of these measures include conducting regular security risk assessments and deploying technologies that protect access to patient information such as Multi-Factor Authentication (MFA) and encryption.

 

Complying with the provisions specified under HIPAA should not only be seen as a legal or regulatory obligation but as accreditation that the organization takes patient confidentiality and security seriously. It helps build that vital trust factor as patients know that the entity has implemented the necessary safeguards needed to protect the privacy of their sensitive medical information. Achieving HIPAA compliance should therefore not be seen as a regulatory obligation but as an essential business practice that builds patient trust.

The Healthcare Industry is Not Immune to Cybersecurity Risks

As the world has become more digital and many of the vital services that run our lives have moved online, cybersecurity is a fundamental principle that every organization needs to put into practice. No enterprise is immune from a cyberattack, and this fact is particularly true for organizations that operate in the healthcare industry.

 

According to the 2018 Verizon Protected Health Information Data Breach Report, 58% of incidents involved insiders. This statistic highlighted the fact that healthcare is the leading industry in which internal actors are the biggest threat to an organization. It’s interesting to note that the majority of these incidents involved human error.

 

Although malicious actions such as misuse of information, physical intrusion, and hacking also contributed to breaches involving the healthcare industry, human error was a leading cause of data compromise. These statistics show the vital role HIPAA can play in helping organizations reduce the risk of data breaches involving protected health information.

How to Comply with HIPAA Rules

HIPAA compliance is not a one time exercise but an ongoing assessment that involves a synchronized endeavor involving people, processes, and technology. As human error is the leading cause of data breaches in the healthcare industry, it is vitally important to implement the safeguards that HIPAA has created to reduce the risk of intentional or accidental compromise of patient healthcare information.

 

Under HIPAA, there are specific obligations that are required and others that are addressable. Required safeguards are mandatory for any organization that stores, processes, or transmits electronically protected healthcare information. Addressable provisions are not mandatory, but organizations need to either implement these or provide evidence that shows that these are not relevant to their specific circumstances.

 

The HIPAA Privacy Rule deals with protected health information (PHI) in general.  The HIPAA Security Rule provides compliance regulations for electronic PHI (ePHI). Under this section of the Act, there are various administrative, physical, and technical safeguards that offer the appropriate measures healthcare organizations need to implement to ensure patient privacy and the security of their ePHI.

 

Administrative safeguards include actions such as undertaking risk analysis and performing an information system activity review. It also recommends that organizations conduct regular cybersecurity awareness training and create an incident response plan.

 

Physical safeguards include measures such as deploying facility access controls and implementing the necessary steps to securely and safely dispose of media that contain ePHI.

Finally, the technical safeguards specified under HIPAA’s security rule include legislative obligations that healthcare organizations need to implement such as ensuring unique user identification, creating an emergency access procedure, and installing technologies that provide data integrity and transmission security.

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HIPAA regulatory actions on failure to comply with breach rules

HIPAA regulatory actions on failure to comply with breach rules | HIPAA Compliance for Medical Practices | Scoop.it

Caps on HIPAA penalties restrict OCR's ability to enforce proportionately

OCR Director Roger Severino said at the 2018 HIPAA NIST/ OCR conference, that it may be necessary for them to revisit the caps in HIPAA enforcement actions.  When asked about the inconsistency among different federal agencies on the amounts of penalties levied for data breaches, Director Severino said that having consistency or standard among agencies may not be easy to accomplish.  On the HIPAA side, there are caps on the penalties that can be levied.  He admitted that it may be necessary to take another look at these caps to ensure fairness and proportionality for judgments.  If a company is so large that a multi-million dollar fine may not be a big impact for them, then the caps may actually be hindering OCR’s ability to impose an appropriate enforcement action on such a company.

HIPAA enforcement highlights

The OCR Director highlighted their recent HIPAA enforcement highlights and provided some details behind those cases.  Some of the cases he discussed were how one covered entity left unprotected medical records on an open truck, one entity mentioned a patient’s name on a press release, insufficient monitoring of logs to detect incidents and how film crews were allowed into a medical center without prior authorization.

$45, 360, 383 is the total amount collected by OCR in HIPAA enforcement actions from January 1, 2017, to October 15, 2018.  They have exceeded $100 million in collection amounts from 2008 onwards.

Regulatory actions against entities that fail to report breaches

When asked about the future of the desk audit program, Director Severino indicated that while they are pleased with the number of entities coming forward to report their breaches, OCR may now focus some energy on entities who have not reported their breaches in accordance with the breach notification rule. They may look into taking regulatory action against entities who do not report breaches as required.  

A note to all healthcare entities – If you suffer from a reportable breach, make sure you adhere to breach notification rules and procedures in a timely manner as dictated by law.

 

Healthcare Information is a precious resource 

Director Severino closed his address by saying that healthcare information is like a bar of gold.  There are bad people who want access to it. 

  • Store it in a safe place.
  • Put a perimeter of defenses.
  • Train your personnel.
  • Monitor your logs.
  • Do your risk analysis. 
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The Benefits of HIPAA Compliance Services for Physicians

The Benefits of HIPAA Compliance Services for Physicians | HIPAA Compliance for Medical Practices | Scoop.it

As a doctor, you have your hands full just taking care of your many patients, running a practice, and providing quality healthcare service. The last thing you need to worry about is whether your practice is being managed properly when it comes to Health Insurance Portability and Accountability Act (HIPAA) compliance.

 

HIPAA regulations can be complex – at least to an inexperienced or understaffed office management team – and there’s no margin of error for unintended breaches that can lead to costly penalties. That’s why it’s important that your practice utilizes professional HIPAA compliance services that offer these key benefits:

Protection against rampant data breaches

HIPAA data breaches happen at an alarming rate. Employee carelessness is a major contributing factor.  According to the HIPAA JournalData breaches caused by employee carelessness have increased year on year. More unencrypted devices are being lost, data still is being inadvertently disclosed, and simple email errors are still being made. Performing regular training on data privacy and security can help to reduce the number of data breaches suffered.”

 

To reduce – if not eliminate – your risk, you may need on-site compliance experts who are not only able to answer your questions at every step during the process, but who can educate and empower your workforce. These experts can provide real-time advice for best practices for securely handling protected health information, protecting patient privacy, and understandinghow to avoid potential breaches.

A customized HIPAA risk management plan

No two practices are alike. Which is why your HIPAA risk management plan must be unique for your practice. Look for a compliance service provider with decades of experience in internal investigations, regulatory compliance, inspection, facility security, risk mitigation, and health information technology can give your practice an invaluable preventative edge.

Supporting evidence that your practice is exercising due diligence

The greater your medical practice can demonstrate its efforts to exercise reasonable diligence to mitigate risk, the greater your chances of avoiding civil monetary penalties. In the event of a breach of electronic medical records, or if your practice is subjected to a HIPAA compliance investigation, your compliance services provider can provide assistance in sufficiently answering any questions the HHS Office for Civil Rights (OCR) may ask about your compliance program.

 

Colington Consulting takes the uncertainty out of what is reasonable and appropriate for HIPAA compliance for your practice. We provide HIPAA risk assessments and on-site facility security surveys by our team of experts. Unlike other service providers that use web-based formats and expect you to answer questions you can hardly understand, we always conduct the assessment, value your input, and use a common-sense approach to compliance.

 

We are experts in the field of HIPAA rules and procedures. Colington Consulting can help you avoid problems and steep fines by bringing your practice into complete HIPAA compliance. It is what we do best, allowing you to do what you do best … provide health care to your patients.

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How Do I Become HIPAA Compliant?

How Do I Become HIPAA Compliant? | HIPAA Compliance for Medical Practices | Scoop.it

For healthcare providers, HIPAA compliance is a must. HIPAA guidelines protect patients’ health information, ensuring that it is stored securely, and used correctly.

 

Sensitive data that can reveal a patient’s identity must be kept confidential to adhere to HIPAA rules. These rules work on multiple levels and require a specific organizational method to implement comprehensive privacy and security policies to achieve compliance.

 

Most organizations find this to be a daunting task. We have put together a HIPAA compliance checklist to make the process easier.

 

The first is to understand how HIPAA applies to your organization. The second is to learn how to implement an active process, technology, and training to prevent a HIPAA-related data breach or accidental disclosure. Finally, the third is to put physical and technical safeguards in place to protect patient data.

By the time you’re done with our list, you will know what you need to consider to have a better conversation with your compliance advisors.

What is HIPAA?

Before talking about compliance, let’s recap the basics of HIPAA.

Signed into law by President Bill Clinton in 1996, the Health Insurance Portability and Accountability Act provides rules and regulations for medical data protection.

HIPAA does several important things. It reduces health care abuse and fraud and sets security standards for electronic billing of healthcare. It also does the same for the storage of patients’ healthcare information. The Act mandates the protection and handling of medical data, ensuring that healthcare data is kept private.

The part of HIPAA we are concerned with relates to healthcare cybersecurity. To be compliant, you must protect patients’ confidential records.

HIPAA rules have evolved. When the law was first enacted, it did not mention specific technology. As the HIPAA compliant cloud has become commonplace, it has inspired additional solutions. For example, our Data Security Cloud (DSC) is being developed to create a base infrastructure for a HIPAA compliant solution. Providing a secure infrastructure platform to ride on top of, DSC makes creating a HIPAA-compliant environment easier.

Secure infrastructure handles things at the lowest technical level that creates data, providing the key features to keep data safe. These features include separation/segmentation, encryption at rest, a secure facility at the SOC2 level of compliance, and strict admin controls among other required security capabilities.

 
 

Why Is HIPAA Compliance Important?

HIPAA compliance guidelines are incredibly essential. Failure to comply can put patients’ health information at risk. Breaches can have a disastrous impact on a company’s reputation, and you could be subject to disciplinary action and strict violation fines and penalties by CMS/OCR.

Last year’s Wannacry ransomware attack affected more than 200,000 computers worldwide, including many healthcare organizations. Most notably, it affected Britain’s National Health Service, causing serious disruptions in the delivery of health services across the country.

To gain access to the systems, hackers exploited vulnerabilities in outdated versions of Windows that are still commonly used in many healthcare organizations. With medical software providers offering inadequate support for new OS’s and with medical devices such as MRIs lacking security controls, the attack was easy to carry out.

The attack demonstrated the strength of today’s hackers, highlighting the extent to which outdated technologies can pose a problem in modern organizations. This is precisely why HIPAA also regulates some aspects of technology systems used to store, manage, and transfer healthcare information.

The institutions that fail to implement adequate systems can suffer significant damage. If a breach takes place, the law requires affected organizations to submit various disclosure documents, which can include sending every subject a mailed letter. They may also be required to offer patients a year of identity protection services.  This can add up to significant dollars, even before confirming the extent of the breach.

 

What is the HIPAA Privacy Rule?

The HIPAA Privacy Rule creates national standards. Their goal is to protect medical records and other personally identifiable health information (PHI).

It applies to three types of companies: providers, supply chain (contractors, vendors, etc.) and now service providers (such as data centers and cloud services providers). All health plans and healthcare clearinghouses must be HIPAA compliant.

The rules also apply to healthcare providers who conduct electronic health-related transactions.

The Privacy Rule requires that providers put safeguards in place to protect their patients’ privacy. The safeguards must shield their PHI. The HIPAA Privacy Rule also sets limits on the disclosure of ePHI.

It’s because of the Privacy Rule that patients have legal rights over their health information.

These include three fundamental rights.

    • First, the right to authorize disclosure of their health information and records.
    • Second, the right to request and examine a copy of their health records at any time.
    • Third, patients have the right to request corrections to their records as needed.

The HIPAA Privacy Act requires providers to protect patients’ information. It also provides patients with rights regarding their health information.

 

What Is The HIPAA Security Rule

The HIPAA Security Rule is a subset of the HIPAA Privacy Rule. It applies to electronic protected health information (ePHI), which should be protected if it is created, maintained, received, or used by a covered entity.

The safeguards of the HIPAA Security Rule are broken down into three main sections. These include technical, physical, and administrative safeguards.

Entities affected by HIPAA must adhere to all safeguards to be compliant.

Technical Safeguards

The technical safeguards included in the HIPAA Security Rule break down into four categories.

    • First is access control. These controls are designed to limit access to ePHI. Only authorized persons may access confidential information.
    • Second is audit control. Covered entities must use hardware, software, and procedures to record ePHI. Audit controls also ensure that they are monitoring access and activity in all systems that use ePHI.
    • Third are integrity controls. Entities must have procedures in place to make sure that ePHI is not destroyed or altered improperly. These must include electronic measures to confirm compliance.
    • Finally, there must be transmission security. Covered entities must protect ePHI whenever they transmit or receive it over an electronic network.

The technical safeguards require HIPAA-compliant entities to put policies and procedures in place to make sure that ePHI is secure. They apply whether the ePHI is being stored, used, or transmitted.

Physical Safeguards

Covered entities must also implement physical safeguards to protect ePHI. The physical safeguards cover the facilities where data is stored, and the devices used to access them.

Facility access must be limited to authorized personnel. Many companies already have security measures in place. If you don’t, you’ll be required to add them. Anybody who is not considered an authorized will be prohibited from entry.

Workstation and device security are also essential. Only authorized personnel should have access to and use of electronic media and workstations.

Security of electronic media must also include policies for the disposal of these items. The removal, transfer, destruction, or re-use of such devices must be processed in a way that protects ePHI.

Administrative Safeguards

The third type of required safeguard is administrative. These include five different specifics.

    • First, there must be a security management process. The covered entity must identify all potential security risks to ePHI. It must analyze them. Then, it must implement security measures to reduce the risks to an appropriate level.
    • Second, there must be security personnel in place. Covered entities must have a designated security official. The official’s job is to develop and implement HIPAA-related security policies and procedures.
    • Third, covered entities must have an information access management system. The Privacy Rule limits the uses and disclosures of ePHI. Covered entities must put procedures in place that restrict access to ePHI to when it is appropriate based on the user’s role.
    • Fourth, covered entities must provide workforce training and management. They must authorize and supervise any employees who work with ePHI. These employees must get training in the entity’s security policies. Likewise, the entity must sanction employees who violate these policies.
    • Fifth, there must be an evaluation system in place. Covered entities must periodically assess their security policies and procedures.

Who Must Be HIPAA complaint?

There are four classes of business that must adhere to HIPAA rules. If your company fits one of them, you must take steps to comply.

The first class is health plans. These include HMOs, employer health plans, and health maintenance companies. This class contains schools who handle PHI for students and teachers. It also covers both Medicare and Medicaid.

The second class is healthcare clearinghouses. These include healthcare billing services and community, health management information systems. Also included are any entities that collect information from healthcare entities and process it into an industry-standard format.

The third class is healthcare providers. That means any individual or organization that treats patients. Examples include doctors, surgeons, dentists, podiatrists, and optometrists. It also includes lab technicians, hospitals, group practices, pharmacies, and clinics.

The final class is for business associates of the other three levels. It covers any company that handles ePHI such as contractors, and infrastructure services providers. Most companies’ HR departments also fall into this category because they handle ePHI of their employees. Additional examples include data processing firms and data transmission providers. This class also includes companies that store or shred documents. Medical equipment companies, transcription services, accountants, and auditors must also comply.

If your entity fits one of these descriptions, then you must take steps to comply with HIPAA rules.

What is the HIPAA Breach Notification Rule?

Even when security measures are in place, it’s possible that a breach may occur. If it does, the HIPAA Breach Notification Rule specifies how covered entities should deal with it.

The first thing you need to know is how to define a breach. A breach is a use or disclosure of PHI forbidden by the Privacy Rule.

The covered entity must assess the risk using these criteria:

    1. The nature of the PHI involved, including identifying information and the likelihood of re-identification;
    2. The identity of the unauthorized person who received or used the PHI;
    3. Whether the PHI was viewed or acquired; and
    4. The extent to which the risk to the PHI has been mitigated.

Sometimes, PHI may be acquired or disclosed without a breach.

The HIPAA rules specify three examples.

  • The first is when PHI is unintentionally acquired by an employee or person who acted in good faith and within the scope of their authority.
  • The second is inadvertent disclosure of PHI by one authorized person to another. The information must not be further disclosed or used in a way not covered by the Privacy Rule.
  • The third occurs if the covered entity determines that the unauthorized person who received the disclosure would not be able to retain the PHI.

 

If there is a breach as defined above, the entity must disclose it. The disclosures advise individuals and HHS that the breach has occurred.

 

Personal disclosures must be mailed or emailed to those affected by the breach. A media disclosure must be made in some circumstances. If more than 500 people in one area are affected, the media must be notified.

 

Finally, there must also be a disclosure to the HHS Secretary.

The HIPAA Breach Notification Rule protects PHI by holding covered entities accountable. It also ensures that patients are notified if their personal health information has been compromised.

 

What Are The HIPAA Requirements for Compliance

The common question is, how to become HIPAA compliant?

The key to HIPAA compliance certification is to take a systematic approach. If your entity is covered by HIPAA rules, you must be compliant. You must also perform regular audits and updates as needed.

 

With that in mind, we’ve compiled a comprehensive checklist for use in creating your HIPAA compliance policy.

HIPAA Compliance Checklist

These questions cover the components to make you are HIPAA-compliant. You can use the checklist to mark each task as you accomplish it. The list is intended to be used for self-evaluation.

Have you conducted the necessary audits and assessments according to National Institutes of Standards and Technology (NIST) Guidelines?

 

The audits in question involve security risk assessments, privacy assessments, and administrative assessments.

Have you identified all the deficiencies and issues discovered during the three audits?

 

There are several things to consider before doing the self-audit checklist. You need to ensure that all security, privacy, and administrative deficiencies and issues are appropriately addressed.

 

Have you created thorough remediation plans to address the deficiencies you have identified?

After covering the deficiencies and issues mentioned above, you need to provide remediation for each group.

Do you have policies and procedures in place that are relevant to the HIPAA Privacy Rule, the HIPAA Security Rule, and the HIPAA Breach Notification Rule?

 

You must be aware of these three critical aspects of a HIPAA compliance program and ensure each is adequately addressed.

    • Have you distributed the policies and procedures specified to all staff members?
      • Have all staff members read and attested to the HIPAA policies and procedures you have put in place?
      • Have you documented their attestation, so you can prove that you have distributed the rules?
      • Do you have documentation for annual reviews of your HIPAA policies and procedures?
    • Have all your staff members gone through basic HIPAA compliance training?
      • Have all staff members completed HIPAA training for employees?
      • Do you have documentation of their training?
      • Have you designated a staff member as the HIPAA Compliance, Privacy, or Security Officer as required by law?
    • Have you identified all business associates as defined under HIPAA rules?
      • Have you identified all associates who may receive, transmit, maintain, process, or have access to ePHI?
      • Do you have a Business Associate Agreement (Business Associate Contract) in place with each identify you have identified as a Business Associate?
      • Have you audited your Business Associates to make sure they are compliant with HIPAA rules?
      • Do you have written reports to prove your due diligence regarding your Business Associates?
    • Do you have a management system in place to handle security incidents or breaches?
      • Do you have systems in place to allow you to track and manage investigations of any incidents that impact the security of PHI?
      • Can you demonstrate that you have investigated each incident?
      • Can you provide reporting of all breaches and incidents, whether they are minor or meaningful?
      • Is there a system in place so staff members may anonymously report an incident if the need arises?

As you work your way through this checklist, remember to be thorough. You must be able to provide proper documentation of your audits, procedures, policies, training, and breaches.

As a final addition to our checklist, here is a review of the general instructions regarding a HIPAA compliance audit.

    • If a document refers to an entity, it means both the covered entity and all business associates unless otherwise specified
    • Management refers to the appropriate officials designated by the covered entity to implement policies, procedures, and standards under HIPAA rules.
    • The covered entity must provide all specified documents to the auditor. A compendium of all entity policies is not acceptable. It is not the auditor’s job to search for the requested information.
    • Any documents provided must be the versions in use as of the audit notification and document request unless otherwise specified.
    • Covered entities or business associates must submit all documents via OCR’s secure online web portal in PDF, MS Word, or MS Excel.
    • If the appropriate documentation of implementation is not available, the covered entity must provide examples from “equivalent previous time periods” to complete the sample. If no such documentation is available, a written statement must be provided.
    • Workforce members include:
      • Entity employees
      • On-site contractors
      • Students
      • Volunteers
    • Information systems include:
      • Hardware
      • Software
      • Information
      • Data
      • Applications
      • Communications
      • People

Proper adherence to audit rules is necessary. A lack of compliance will impact your ability to do business.

In Closing, HIPAA Questions and Answers

HIPAA rules are designed to ensure that any entity that collects, maintains, or uses confidential patient information handles it appropriately. It may be time-consuming to work your way through this free HIPAA self-audit checklist. However, it is essential that you cover every single aspect of it. Your compliance is mandated by law and is also the right thing to do to ensure that patients can trust you with their personal health information.

One thing to understand is that it is an incredible challenge to try to do this by yourself. You need professional help such as a HIPAA technology consultant. Gone are the days you can have a server in your closet at the office, along with your office supplies. The cleaning personnel seeing a print out of a patient’s file constitutes a ‘disclosable’ event.

Screen servers, privacy screens, and professionally-managed technology solutions are a must. Just because you use a SAS-based MR (Medical Records) solution, does not mean you are no longer responsible for the privacy of that data. If they have lax security, it is still the providers’ responsibility to protect that data. Therefore the burden of due diligence is still on the provider.

Phoenix NAP’s HIPAA compliant hosting solutions have safeguards in place, as audited in its SOC2 certifications. We provide 100% uptime guarantees and compliance-ready platform that you can use to build secure healthcare infrastructure.

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Is it Time for Your Organization to Hit the HIPAA Breach Panic Button? 

Is it Time for Your Organization to Hit the HIPAA Breach Panic Button?  | HIPAA Compliance for Medical Practices | Scoop.it

Indeed, it is. According to the latest statics from the HHS Office of Civil Rights (OCR), 43% of all reported breaches are now caused by hacking or other related information network discrepancies—not to mention those breaches that are the result of impermissible disclosures made by members of the work force.

 

Let’s face it, breaches will happen, especially those related to information systems. When it comes to breaches, most network security experts say it is “when” and not “if.” Regardless of whether the breach is related to the network or some other means such as lost or stolen devices containing ePHI, what is important is having a process in place to deal with it. This includes the ability to conduct an internal investigation to determine the basics such as how the breach was caused, the type of breach, and how many individuals were affected.

 

The HIPAA Breach Notification Rule states that a breach is, generally, an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information. The exception is when the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors:

  1. The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification;
  2. The unauthorized person who used the protected health information or to whom the disclosure was made;
  3. Whether the protected health information was actually acquired or viewed; and
  4. The extent to which the risk to the protected health information has been mitigated.

 

So, what is the best way to conduct the breach risk assessment to determine this probability? Start with some type of Breach Notification Risk Assessment Tool which is a decision tree-based process. This will help determine if the breach is reportable. Even if the determination is made that the breach is not reportable, documentation that this assessment was conducted must be maintained.

 

Having a comprehensive breach notification policy is critical. This will save a lot of headaches and layout a process to follow during the period of uncertainty associated with a breach. The policy should state the obvious such as who needs to be notified internally within the organization, who is responsible for conducting the assessment, and what specific notifications need to be made. What is even more important is the actual procedure to implement the policy. Procedures should cover how to undertake the investigation of the breach to cover the who, what, how, and when of the occurrence. If it is a reportable breach, this type of information is required for submitting “Notice of a Breach” to the Secretary of HHS (which technically is delegated to OCR.) When submitting the Notice, one should be prepared to answer a number of questions. This is why it is important that the internal investigation uncover as much information as possible.

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What is required for HIPAA Compliance?

What is required for HIPAA Compliance? | HIPAA Compliance for Medical Practices | Scoop.it

Lots of our visitors ask us “what is required for HIPAA compliance?” Because this is such an important question, we try to direct our visitors to the most trusted sources for HIPAA education. The most important aspect to remember is that a checklist based “solution” is my no means affective. What we do endorse is the ability to use a checklist to understand what aspect of HIPAA you are doing, and to recognize ones you may have looked over or need to address in further detail. We recommend taking a look at Compliancy Group who has two resources for your organization, whether you’re a Covered Entity or a Business Associate. First, we recommend reading and downloading their HIPAA compliance checklist. Or you can register for their HIPAA compliance checklist webinar!

 

Some of the key findings in the checklist highlight Business Associate Agreements, and also help point out the need for more than just a security risk assessment. As many are familiar with there is a need for HIPAA training, but we do appreciate how it points out the need for documentation of training and other attestations.

 

HIPAA Compliance Checklist: What You Need to Know

The divide between what is required for compliance under HIPAA regulation and the misconceptions that healthcare professionals have about being compliant is more extensive than ever. When she was appointed in late 2015, Jocelyn Samuels, director of the Office of Civil Rights (OCR) announced her plan to start on a new wave of audits. Extensively reported upon, these Phase 2 audits are reaffirming that the over $10 million in fines levied against non-compliant Covered Entities (CE’s) and Business Associates (BA’s) seen in 2015 alone is set to become the norm, and perhaps even grow over the coming months.

 

Compliancy Group is here to make sure that you’re not the one being hit with these fines. We’ve compiled this HIPAA checklist to help guide you through some of the most often overlooked components of total HIPAA compliance, and to help ready you for this sweeping new series of audits that OCR has lined up.

 

The HIPAA Compliance Checklist: The Privacy Rule

The HIPAA Privacy & Security Rule is a series of national regulations concerned with safeguarding patients’ PHI and medical records from unauthorized access. It gives patients the primary rights over their own health information. The rule applies to health plans, healthcare clearinghouses, and health care providers that make certain electronic healthcare transactions. These groups are required to have appropriate limitations and conditions on the use and disclosure of PHI.

  • Implement written policies, procedures, and standards of conduct: Ensure that you have written training standards as well as written penalties that employees are informed of in the case of a violation.
  • Have BA agreements in place: When conducting business with a BA, you need to ensure that you have comprehensive, up-to-date agreements in place to protect your firm from liability in the event that a BA breaches HIPAA regulation.
  • Data safeguards: Maintain administrative, technical, and physical safeguards to monitor use or disclosure of PHI.
  • Complaints procedures: Implement procedures where patients can file a complaint to the CE about its HIPAA compliance, and patients must be informed that complaints may also be submitted to HHS.
  • Retaliation and waiver: Retaliation can’t be taken out against a patient who exercises their rights under the Privacy Rule. Patients cannot be made to waive their Privacy Rule rights as a means of obtaining treatment, payment, or enrollment.
  • Documentation and record retention: Records of all privacy policies, privacy practice notices, complaints, remediation plans, and other documentation must be stored and accessible for six years after their initial creation.
  • Privacy personnel: Ensure that an appointed privacy officer is in place to develop and implement the rest of these privacy policies.

 

The HIPAA Compliance Checklist: The Security Rule

The HIPAA Security Rule outlines specific regulations that are meant to prevent breaches in the creation, sharing, storage, and disposal of ePHI. Since its adoption, the rule has been used to manage patients’ confidentiality alongside changing technology. And now, with the growing trends of cloud computing and online and remote document sharing, the protection of ePHI is becoming more important than ever.

 

These safeguards each require different standards that need to be implemented in order to be deemed fully compliant. The legal jargon that surrounds each safeguard and standard can be confusing, so we’ve broken them down into a simple, but comprehensive list below.

 

The HIPAA Security Rule Checklist: Administrative Safeguards

Administrative safeguards should be in place to establish policies and procedures that employees can reference and follow to ensure that they’re maintaining compliance. Each of these standards should be documented as a written policy, accessible to all employees so that they understand the necessary steps they should be taking to maintain patients’ confidentiality.

Standard 1. Security Management Process

 

  • Risk Analysis should be done to assess confidentiality of ePHI
  • Risk Management measures should be implemented to assess potential breaches in ePHI
  • Sanction Policies should be extended to employees who fail to comply with policies and procedures
  • Information System Activity Reviews should be in place so that system activity is regularly monitored

Standard 2. Assigned Security Responsibility

  • Security Responsibility should be assigned to an employee who can regularly monitor, develop, and maintain privacy policies and procedures

Standard 3. Workforce Security

  • Employees who are meant to deal with ePHI should undergo Authorization and Supervision
  • Workforce Clearance Procedures should govern who is and isn’t allowed access to ePHI
  • Termination Procedures should be in place so that employees who have left a practice can no longer have access to ePHI that they’ve previously had access to

Standard 4. Information Access Management

  • Clearinghouses that are part of larger organizations need to have properly Isolated Access to ePHI
  • Employees should be given Access Authorization depending on whether or not their role requires that they handle ePHI
  • Access to ePHI should be governed by strict rules for when and how it is granted, Established, or Modified

Standard 5. Security Awareness and Training

  • Security Reminders should be regularly communicated
  • Protection from Malicious Software should be a priority to prevent ePHI from being compromised
  • Log-in Monitoring should be in place to detect any unauthorized access to ePHI
  • Password Management should be implemented for creating, changing, and protecting employees’ passwords

Standard 6. Security Incident Procedures

  • Breaches and their ramifications need to have documented Response and Reporting procedures

Standard 7. Contingency Plan

  • Data Backup Plan is required to ensure that there are ways to retrieve ePHI that has been lost because of a malfunction or a breach
  • Disaster Recovery Plans should be in place to ensure that any lost ePHI can be fully restored
  • Emergency Mode Operation Plans should be established so that employees can properly access and handle ePHI, while maintaining privacy, in the event of an emergency
  • Contingency procedures should be Tested and Revised on an ongoing basis to address faults or flaws
  • Contingency procedures should be go through Applications and Data Criticality Analysis to ensure that contingency plans are as streamlined as possible

Standard 8. Evaluation

  • The technical and non-technical elements of ePHI security should be regularly Evaluated, particularly when moving offices or changing operations

Standard 9. Business Associate Contracts and Other Arrangements

  • Written Contracts or Other Arrangements need to document that BAs will comply with all ePHI security measures.

 

The HIPAA Security Rule Checklist: Physical Safeguards

Physical safeguards should guide the creation of policies and procedures that focus on protecting electronic systems and ePHI from potential threats, environmental hazards, and unauthorized intrusion. And as is the case with administrative safeguards, each of these standards should be documented as a written policy, accessible to all employees so that they understand the necessary steps they should be taking to maintain patients’ confidentiality.

Standard 1. Facility Access Controls

  • Procedures should be in place to establish Contingency Operations plans that allow access to the physical office and stored data in the event of an emergency
  • Facility Security Plan needs to be well established to protect equipment that stores ePHI from unauthorized access and theft
  • Access Controls and Validation Procedures should govern when, how, and to whom access to equipment is granted
  • Maintenance Records should document modifications to the physical facility such as renovations or changing doors or locks

Standard 2. Workstation Use

  • Workstation Use policies need to specify the use, performance, and physical attributes of equipment and workstations where ePHI is accessed

Standard 3. Workstation Security

  • Workstation Security should entail physical safeguards that govern who can access workstations and equipment where ePHI is accessible

Standard 4. Device and Media Controls

  • Disposal of hardware or equipment where ePHI has been stored needs to be strictly managed
  • Policies should be in place to determine how and when ePHI should be removed from equipment or electronic media before Re-use
  • Hardware and equipment that has access to ePHI should be Accountable and, if necessary, tracked
  • Data Backup and Storage procedures should entail the creation of exact copies of ePHI

 

The HIPAA Security Rule Checklist: Technical Safeguards

Technical safeguards are the last piece of the Security Rule. They’re meant to provide written, accessible, policies and procedures that monitor user access to systems that store ePHI.

Standard 1. Access Control

  • Employees should be granted Unique User Identification in the form of a username or ID number that can be used to identify and track system usage
  • Procedures should be in place that determine Emergency Access protocols and authorization
  • Systems that store ePHI should be built with an Automatic Logoff function after inactivity
  • Encryption and Decryption methods should be built into systems that store ePHI

Standard 2. Audit Controls

  • Audit Controls must regularly monitor, record, and store system usage and ePHI access

Standard 3. Integrity

  • In order to ensure that ePHI hasn’t been accessed, altered, or destroyed without authorization, a Mechanism to Authenticate ePHI should be built into the system

Standard 4. Person or Entity Authentication

  • Person or Entity Authentication needs to be in place to ensure that only authorized employees or users have access to certain data and ePHI

Standard 5. Transmission Security

  • Any ePHI that is transmitted electronically needs to be protected by Integrity Controls to ensure that it hasn’t been modified in the process
  • Any stored ePHI should be Encrypted
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New HIPAA requirements target unsecured protected health information

New HIPAA requirements target unsecured protected health information | HIPAA Compliance for Medical Practices | Scoop.it

The American Recovery and Reinvestment Act of 2009, signed by President Barack Obama in February, modified the Health Insurance Portability and Accountability Act (HIPAA). In particular, the Health Information Technology for Economic and Clinical Health Act (HITECH) sets forth new requirements relating to business associates and notification of patients regarding breaches of unsecured protected health information. The new regulation covers breaches that occur after September 23, 2009.

 

Before HITECH, a covered entity, that is, a physician's office, hospital, clinic, etc.—only was required to mitigate the effects of an unauthorized disclosure, which may or may not have included notifying the patient Now, except for certain limited exceptions, a covered entity is required to notify a patient of an unauthorized disclosure of unsecured protected health information if a significant risk of "financial, reputational, or other" harm exists.

 

It is important to note that notification is only required for unsecured protected health information, not secured protected health information. The Department of Health and Human Services (HHS) issued guidance on what constitutes "secured" protected health information in April, stating that information is deemed secured if rendered "unusable, unreadable, or indecipherable" to unauthorized individuals.

 

To determine whether a "significant risk of harm" exists, the covered entity should consider what information was disclosed, to whom the information was disclosed, and what steps have been taken to eliminate or reduce the risk to the individual.

 

Any notification to the patient must include a brief description of what happened and the type of protected health information disclosed, any steps the patient should take to protect himself or herself, what the covered entity is doing to investigate and mitigate the breach, and information concerning who to contact for additional information. Any required notification must occur without unreasonable delay but no more than 60 days after the breach is discovered or should have been discovered with the exercise of reasonable diligence.

 

Notification must be in writing by mail (or by phone in urgent cases) or electronic means if the patient has consented to electronic notification. Also, specific rules exist regarding what to do if patients cannot be located. If a breach involves more than 500 patients—for instance, the loss of a laptop containing unsecured protected health information, then local media outlets must be notified. In addition, the HHS secretary must be notified—immediately for breaches involving more than 500 patients and annually for others.

 

With the new regulations, the knowledge of a covered entity's agents, including business associates, is imputed to the covered entity. Therefore, the clock for notifying patients could begin to run before the covered entity actually is aware of the disclosure. New agreements may be required, and education of business associates is important, to ensure that they are aware of these requirements and that they indemnify your practice if they fail to comply with the new rules and notify you promptly of any breach of protected health information.

 

The burden to disclose the breach or establish that no risk of harm to the patient exists is on the covered entity, even if the breach was the fault of one of its agents. A decision not to notify a patient because the covered entity does not believe that a significant risk of harm exists should be carefully investigated and documented.

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HIPAA Privacy Complaint Results in Federal Criminal Prosecution for First Time

HIPAA Privacy Complaint Results in Federal Criminal Prosecution for First Time | HIPAA Compliance for Medical Practices | Scoop.it

For the first time, a HIPAA privacy complaint filed with the Department of Health and Human Services’ Office for Civil Rights (OCR) has resulted in federal criminal prosecution.

 

A complaint was filed with OCR over an impermissible disclosure of a patient’s protected health information by a doctor. The doctor, Richard Alan Kaye of Suffolk, Va., was alleged to have shared PHI with the patient’s employer without consent from the patient – A violation of the HIPAA Privacy Rule.

 

The case against Kaye has been referred to the Department of Justice, which has pressed charges. While OCR has referred more than 500 HIPAA violation cases in the past, this if the first time that an investigation of a privacy complaint has resulted in criminal prosecution.

 

Kaye had previously worked at Sentara Obici Hospital in Suffolk, Va., as Medical Director of its Psychiatric Care Center. The patient had been enrolled in a mental health treatment program at the hospital and Kaye treated and subsequently discharged the patient. On discharge, Kaye stated that the patient was not a threat to the public.

 

Federal prosecutors allege Kaye shared PHI with the patient’s employer “under the false pretenses that the patient was a serious and imminent threat to the safety of the public, when in fact he knew that the patient was not such a threat.”

 

While it was previously possible for egregious HIPAA violations to result in criminal prosecutions for HIPAA covered entities, filing charges against individuals was problematic. When individuals were discovered to have violated the privacy of patients, and the violations warranted criminal prosecution, it was necessary to file charges under the aiding and abetting theory – The abuse of an individual’s position to violate HIPAA Rules.

 

However, the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act) provided further clarification on criminal prosecutions for HIPAA violations, and made the process of prosecuting individuals for HIPAA privacy violations more straightforward.

 

If cases are investigated and OCR determines HIPAA Rules have been violated by covered entities, the cases are typically resolved by OCR, often via settlements. However, if individuals are alleged to have violated HIPAA Rules, criminal penalties may be appropriate. In such cases, OCR can refer the cases to the Department of Justice, the federal attorney general, and/or state attorneys general to pursue criminal charges against those individuals.

 

While criminal cases have been filed against individuals who violated HIPAA Rules and impermissibly disclosed PHI, the uncertainty of pursuing cases against individuals prior to the passing of the HITECH Act dissuaded federal prosecutors from pursuing cases. Since the HITECH Act was passed, there have been referrals of cases, although this is understood to be the first time that the Department of Justice has actively pursued criminal charges against an individual following the referral of a privacy complaint by OCR.

 

There is no private cause of action in HIPAA. While private citizens can file complaints with the OCR over alleged violations of HIPAA Rules, they are not permitted to file lawsuits against covered entities for HIPAA violations. The lack of criminal penalties for HIPAA violations may have dissuaded patients from filing complaints. Now the Department of Justice is taking action against an individual for an egregious HIPAA privacy violation, it may encourage more patients to file complaints with OCR.

 

This DOJ case shows federal authorities are now taking HIPAA Privacy Rule violations much more seriously. OCR is also training state attorneys general on HIPAA enforcement. After state attorney generals have received training, it is expected they too will take a more aggressive stance against covered entities that have violated the privacy of state residents.

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HIPAA Sees Meritus Medical Center Stop Media Announcements

HIPAA Sees Meritus Medical Center Stop Media Announcements | HIPAA Compliance for Medical Practices | Scoop.it

Meritus Medical Center is one of a number of hospitals that has stopped issuing information about patient conditions to the media. The hospital announced on September 22 that this courtesy would be stopped.

 

The Health Insurance Portability and Accountability Act places certain restrictions on the disclosure of Protected Health Information to third parties, including the media. Just a few years ago, reporters would be able to call a healthcare provider to make an enquiry about the health status of a patient.

 

The hospital staff would provide general information about a particular patient’s condition if they were asked about a patient by name. The information disclosed would be restricted, so reporters would be advised for instance, that a patient was good, fair, stable or in critical condition.

 

Under HIPAA Rules this information may be disclosed to the media; however it is not mandatory for a hospital or healthcare provider to give out any information, except when it is in the public health interest to do so or if required by law enforcement officers to assist with an investigation.

 

HIPAA Rules See Patient Privacy Improved
Since the HIPAA Privacy Rule is now being enforced, and covered entities can face considerable fines for violations of the Rules covering the disclosure of PHI, many hospitals have now taken the decision to stop releasing any information on patients. They see it as a measure that will improve privacy and help avoid any inadvertent HIPAA violations.

 

In the case of Meritus Medical Center it was not only the risk of HIPAA violations, but the policy was changed to improve privacy standards for patients. Meritus Communications Manager, Nicole Jovel, said in a media announcement “In conversations with clinicians and administrators, we determined we needed to really increase the level of privacy we were providing.”

 

A Patient’s Status can Rapidly Change
There are also problems with such a simple classification of status and providing information when it is likely to change. Patients may slip from serious to critical, or may improve from one day to the next. It would not be fair to report a condition, if that information may be incorrect just a few hours later. In the case of newspapers which are printed the following day, they may contain inaccurate information before they even hit consumers’ doorsteps.

 

Patient Safety is a Major Consideration
Then there is the issue of confirming the identity of the caller, which in often impossible. The hospital treats numerous victims of domestic violence, and Jovel pointed out that the staff cannot be sure if they are giving information to an abusing partner.

The problem faced by Meritus is typical. There are too many variables to consider, and in a busy healthcare setting it is too easy for mistakes to be made. Ultimately those mistakes could prove detrimental to patients and the decision is made to stop issuing all reports to the media.

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Fax Sent to Wrong Number Results in HIPAA Violation

Fax Sent to Wrong Number Results in HIPAA Violation | HIPAA Compliance for Medical Practices | Scoop.it

One morning, the office manager got a call from one of the practice's patients, Mr. M, a 52-year-old, HIV-positive man who had been seeing Dr. G for a decade. Although he was happy with the treatment he had been receiving, Mr. M's company was promoting him and he was relocating to another town. He called to ask Dr. G to fax his medical records to his new urologist.

 

The office manager was juggling numerous tasks, but managed to send the fax out later that day. The office did not have personalized fax cover sheets, just sheets that the office manager printed off once a week which had spaces to fill in the “to” and “from” sections. She hurriedly filled them in and shot off the fax, one of several she had to do before checking in the next patient.

 

At the end of the day she told Dr. G that it had been done. He thought nothing of it until the following Monday when the office manager came into the back office to speak to him. She was pale and looked shaken, and the physician immediately asked if she was okay.

 

“It's Mr. M,” the office manager said. “He just called – absolutely furious. He says that we faxed his medical records to his employer rather than his new doctor, and that now his company is aware of his HIV status. He is extremely upset.”

 

“I'm so sorry,” the office manager said tearfully. “I was the one who sent that fax out. I must have accidentally grabbed the wrong number from his file. What should we do?” She looked at Dr. G for guidance.

 

Dr. G was holding his forehead, and trying to figure out how to remedy the situation. “The first thing we're going to do is to call Mr. M and apologize. Then we'll take it from there.”

 

The office manager and Dr. G called Mr. M and apologized profusely for the mix-up. Mr. M understood that it had not been done maliciously, but he was still not satisfied and reported the incident to the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR).

 

An initial investigation indicated that the incident was not criminal and so it was not referred to the Department of Justice.

 

Rather, it was handled by the OCR. OCR officials appeared at Dr. G's office to look into the matter, and after a thorough investigation, the OCR issued a letter of warning to the office manager, referred the office staff for HIPAA privacy training, and had the office revise the fax cover sheets to underscore that they contain a confidential communication for the intended recipient only.

 

Legal Background
The Health Insurance Portability and Accountability Act, commonly known as HIPAA, protects personally identifiable health information of patients, and specifies to providers how such information may be used. HIPAA has been in effect for about a decade, and in that time, the HHS has received a total of almost 80,000 complaints.

 

Of those, more than 44,000 were dismissed, 19,000 were investigated and resolved with changes to privacy practice, and 9,000 were investigated but no violations were found. According to HHS, private medical practices were the ones most often required to take corrective action as a result of enforcement.

 

The top two compliance issues most frequently investigated are impermissible use and disclosure of protected health information and lack of safeguards for protected health information.

 

When a HIPAA complaint is filed with the HHS, the first determination made is whether there was a possible privacy violation and whether it was of a criminal nature. If it was determined to be criminal, the case is referred to the Department of Justice for investigation and possible prosecution.

 

If it was determined that it was not a criminal issue (as in this case) the violation is investigated by the OCR. If it is determined that a HIPAA violation did, in fact, take place, the OCR can either obtain voluntary compliance, corrective action or some other voluntary agreement with the offender, or the OCR can issue a formal finding of violation and force the offender to change its practices.

 

In this particular case, the office manager and Dr. G recognized the mistake and immediately tried to take corrective action by apologizing to the patient. Dr. G's office also voluntarily agreed to extra compliance training for the staff and to a change in their faxing procedures to indicate that the faxed materials are confidential.

 

Protecting Yourself
This particular scenario was the result of a careless error. While a careless error can happen to anyone, one such as this could cause irreparable harm to the patient if his employer now views or treats him differently because of the new knowledge of his HIV-positive status.

 

Confidential patient records must be treated with the greatest of care as they contain information of an extremely personal nature. Many HIPAA cases have involved the unintentional divulging of the HIV or AIDS status of a patient.

 

In a similar case, a dental practice was reported for using red stickers and the word AIDS on the outside of patient folders. And in a case that took place in a hospital, a nurse and orderly lost their jobs for discussing a patient's HIV status within earshot of other patients.

 

A good rule of thumb is to treat a patient's confidential information as you would want yours to be treated, and then add a little extra security for good measure.

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Protecting PHI: Managing HIPAA Risk with Outside Consultants 

Protecting PHI: Managing HIPAA Risk with Outside Consultants  | HIPAA Compliance for Medical Practices | Scoop.it

The rising complexity of healthcare, particularly as it relates to providers’ growing technical needs, is increasingly prompting healthcare organizations to seek the help of outside consultants. In engagements with healthcare entities, thought IT consultants try to minimize interaction with patient data, they often have access to protected health information (PHI). When working with HIPAA Covered Entities, consultants are treated as “business associates” and are required to comply with Privacy Rules designed to protect PHI.

 

Managing HIPAA compliance when engaging outside consultants requires that consultants enter into a Business Associate Agreement (BAA). The BAA must:

  • Describe the permitted and required uses of PHI by the business associate in the context of their role
  • Provide that the business associate will not use or further disclose the PHI, other than as permitted or required by the contract or by law
  • Require the business associate to use appropriate safeguards to prevent a use or disclosure of the PHI, other than as provided for by the contract

Here are several best practices to follow to ensure the protection of PHI in consulting arrangements.

 

FTE Mentality

During the contract period, the expectation is that consultants act as if they were an employee of the hospital or provider organization and therefore treat PHI in this manner. It is important to know that consultant business associates could be held liable or equally responsible for a PHI data breach in the same way a full-time employee could be.

 

Role-Based Access Rules

Limit access to PHI based on role to ensure that only the parties that need PHI have access to it. An IT strategist, for example, does not need to see live patient data. Associates leading implementation projects, on the other hand, may need access to live PHI. Typically, this occurs late in the implementation process, when the time comes to test a system with live, identifiable patient data.

 

Safeguard Access Points

If a hospital wants a consultant to have regular access to PHI, it would be preferable that the hospital provides the consultant with a computer or device with appropriate access authorizations and restrictions in place. Avoid the use of personal devices whenever possible. Make sure that only approved and authorized devices can be used inside the firewall and require multi-factor authentication during log-in. Avoid inappropriate access to PHI by way of shared or public data access points. Don’t allow private access to PHI where others could intervene.

 

Keep it Local

Don’t take PHI away from the source of use. Consultants should avoid storing PHI on personal devices, including smart phones, which are particularly susceptible to theft and loss. Devices used to store or access PHI must be registered. Best practices often include controls giving IT staff advance permission to remotely wipe or lock a stolen registered device. Avoid leaving registered devices in cars or unprotected areas.

 

Paper-based reports also pose threat of PHI leak. Documents you take home over the weekend, for example, could be accessed by family members, lost, or stolen. Electronic, paper, verbal and image-based PHI should all be confidently secured. Of course the regulations also relate to visual and verbal protections. When accessing PHI avoid allowing others to view your screen over your shoulder. When discussing PHI make sure only those who need to know and have appropriate authority can hear the conversation.

 

The healthcare industry is making great strides in establishing digital infrastructure, much of which is cloud-based, putting new onus on providers and their business partners to ensure the security of that information. No one wants to make headlines for the latest data breach, least of all the IT consultants hired by providers to help guide their data management efforts. Rigorous attention to HIPAA Privacy Rule guidelines is not only required – it’s imperative to maintaining trust in the healthcare ecosystem.

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HIPAA Police –Are They Coming For You?

HIPAA Police –Are They Coming For You? | HIPAA Compliance for Medical Practices | Scoop.it

As reported by Health and Human Services (HHS) HIPAA fines and audits are significantly on the rise. 5% of practices are being audited against the HITECH Act and Omnibus Rule. Are you compliant?

 

“How do all these regulations affect me as a Healthcare Covered Entity or Business Associate?”

To answer that question, let’s first look at what the regulations are and get a brief description. Once we read and understand what we are facing, the steps to complying with the rules should be attainable. I would love to say attaining compliance is easy, but with anything in life, if you want success you will have to work for it.

 

HITECH ACT

The Health Information Technology for Economic and Clinical Health Act (HITECH Act) was created to motivate the implementation of electronic health records (EHR) and supporting technology in the United States. President Obama signed HITECH into law on February 17, 2009, as part of the American Recovery and Reinvestment Act of 2009 (ARRA).

 

The HITECH act specified that by the beginning of 2011, healthcare providers would be given monetary incentives for being able to demonstrate Meaningful Use (MU) of electronic health records (EHR). These monetary incentives, up to $44,000 per doctor, will be offered until 2016, after which time penalties will be levied for failing to demonstrate such use.

 

FYI, the main failure that the centers for Medicare and Medicaid have discovered when auditing providers who have implemented an EHR system is their failure to perform a proper Risk Analysis.

 

OMNIBUS RULE

The United States Government’s requirement to implement Electronic Medical Records and Health IT compliance has prompted the US Government to adopt the long-awaited HIPAA Omnibus Rule http://compliancy-group.com/hipaa-omnibus-rule

The Omnibus Rule was finalized by the Office for Civil Rights (OCR). The Office of Management and Budget (OMB) approved the final rule and subsequently published it in the Federal Register.

 

The rule effectively merges four separate rulemakings, which are as follows:

  • Amendments to HIPAA Privacy and Security rules requirements;
  • HIPAA and HIPAA HITECH under one rule now
  • Further requirements for data breach notifications and penalty enforcements
  • Approving the regulations in regards to the HITECH Act’s breach notification rule

 

It is apparent for this new rule that the health care industry will need to educate patients with regards to their privacy and disclosure rights. Patients will need to know how their information is used and disclosed, and how to submit complaints pertaining to privacy violations. Health Care providers should also try to better understand HIPAA requirements so that they are aware of their risks and responsibilities towards their patients.

 

In addition, the Omnibus Rule includes provisions that would govern the use of patient information in marketing; eliminates and modifies the “harm threshold” provision that presently allows healthcare providers to refrain from reporting data breaches that are deemed not harmful; ensures that business associates and subcontractors are liable for their own breaches and requires Business Associates to comply with HIPAA for the first time since HIPAA was first introduced. The rule also requires HIPAA privacy and security requirements to be employed by business associates and sub-contractors.

 

So, what does compliance with these rules look like? Is it a 3-ring binder on a shelf with some policies, is it an online training course, or is it my IT person telling me I am protected? Actually, it is a little of all three.

  1. RISK ANALYSIS– A true risk analysis covering Administrative, (Policies and Procedures), Technical, (How are your Network, Computers, Routers, protected), Physical, What safeguards have you put into place at your location? (Alarms, Shredding, Screen Protectors).
  2. RISK MANAGEMENT- The risk analysis is going to identify deficiencies. Risk Management is then put in place to track how your remediation plan will work to fix the deficiencies that were found during the Risk Analysis.
  3. VENDOR MANAGEMENT– Vendor Management tracks the companies and people that access your site where PHI or ePHI is stored and keeps track of who you share PHI or ePHI with. Depending on the relationship, you will want to have either a Business Associate Agreement (if they meet the requirements for being labeled a Business Associate) or a Confidentiality Agreement. Remember, for Business Associates, an agreement alone is not enough; you also need assurances that they are complying with the HIPAA Security Rule before you share or continue to share PHI or ePHI with them.
  4. DOCUMENT MANAGEMENT– It is hard to imagine compliance without a place to store policies, procedures, business associate agreements, or any other compliance documents. Why you ask? Because the rule specifically states that you must retain all compliance documents for a min of 6 years (depending on the state your business is in these rules may be more stringent).

5. TRAINING OF YOUR STAFF– One of the most important aspects of compliance is the tracking of not only HIPAA 101 training for your staff but also of your staff’s acknowledgment that they understand the HIPAA Privacy and Security Policies that you

 
 
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The Benefits of Performing a HIPAA Risk Assessment

The Benefits of Performing a HIPAA Risk Assessment | HIPAA Compliance for Medical Practices | Scoop.it

The Health Insurance Portability and Accountability Act (HIPAA) Security Rule mandates that covered entities must conduct a risk assessment of their healthcare company.

 

 A wide range of organizations – from healthcare insurance providers to hospitals – fall into this covered entity group. While it may seem taxing and time-consuming to provide standardized training to your employees, there are many reasons doing so can behoove you. For one, it’s the law. Since 2009, Security Risk Assessments (SRAs) have been a required annual practice set forth by the HIPAA Security Rule.

 

Don’t wait to become a breach headline; nip breaches in bud by detecting security issues before they wreak havoc. You can’t be secure if you are not compliant; and a HIPAA Risk Assessment will safeguard your organization in more ways than one. Technology is a timesaver that has simplified the medical filing and billing processes, but it leaves the potential for leaks and hacking.

 

A risk analysis will identify and document potential threats and liabilities that can cause a breach of sensitive data. An IT security consulting company can check all portable media (laptops), desktops, and networks to ensure they’re ironclad. IT security measures, such as encryption and two-factor authentication2, will be addressed in order to make it challenging for unwanted eyes to get a glimpse of patient information.  

 

Employees are the greatest threat to HIPAA compliance, so it’s important to make sure they’re well informed on how to prevent breaches. Annual HIPAA Security Awareness Training Programs provide a thorough understanding of each person’s role in preventing breaches and protecting physical and electronic information.

 

HIPAA training is a regulatory requirement, many employee actions that go awry could easily be prevented. A consultant will offer tips and tricks for minimizing that risk; a few include never leaving work phones and laptops unattended, never sharing passwords or company credentials, choosing to shred files as opposed to trashing them, and overcoming the temptation to “snoop” on patient information without just cause.

 

While many of these suggestions seem like common sense, there are also many lesser known incidences that arise while working in the medical field. Did you know that you cannot access your own medical records using your login credentials? While it may seem innocent enough, everyone is required to submit a request to access medical materials. 

 

Don’t deter a Risk Assessment out of indolence. HIPAA Risk Assessments must be accurate and extremely thorough.  Questions about all the administrative, technical, and physical safeguards an organization has in place must be asked about.

 

If outsourcing your HIPAA Risk Assessment, choose a company that provides comprehensive training courses. No two companies are alike so cookie-cutter answers don’t exist for compliancy; a client-facing doctor’s office and corporate health insurance agency will require that different preventive measures be put into place.

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HIPAA Training is not HIPAA Compliance

HIPAA Training is not HIPAA Compliance | HIPAA Compliance for Medical Practices | Scoop.it

We hear from so many doctors’ and dentists’ offices that they are “HIPAA-compliant” because they have completed the required annual HIPAA training for their staff.   FALSE! HIPAA Training is not HIPAA Compliance. HIPAA Training is only one of the components of HIPAA Compliance – thinking otherwise could lead to a false sense of security.

 

HIPAA law consists of various requirements in the areas of security and privacy, use and disclosure of PHI (protected health information) and in breach notification rules.

Minimum steps needed for HIPAA Compliance:

At the very minimum, a doctor’s or dentist’s office must do the following for HIPAA Compliance:

  1. Exercise privacy in the office everywhere.   Be careful about accidental disclosure of patient information.
  2. Display the Notice of Privacy Practices prominently in your office lobby and on your website.
  3. Exercise caution in the use and disclosure of PHI (Protected Health Information).     Patients have the right to review and obtain their PHI.   The onus falls on the medical practice to secure and protect PHI from unauthorized disclosure of any kind.
  4. Conduct the mandatory annual risk assessment, or hire an expert to conduct it for you.   The assessor must take into consideration all the security and privacy-related criteria while conducting the assessment, including all your administrative, physical and technical safeguards.   A detailed list of recommendations and action items should follow as a result of the risk assessment.
  5. Prepare and follow security and privacy policies and procedures.   Your risk assessment should highlight the minimum required policies and procedures that you would need to prepare or obtain.   Physicians and staff members should be familiar with and should follow these policies and procedures on a daily basis.
  6. Provide annual HIPAA Training to your staff and physicians.

Breach notification:

Breaches have unfortunately become only too common these days in an environment where medical records are extremely valuable in the black market.   HIPAA law also specifies strict breach notification requirements in the event of a breach.   The Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS) requires the practice to inform all individuals whose data might have been lost or stolen.  

 

A breach of more than 500 records is considered a reportable breach, that is, the practice must notify HHS.   This could result in an audit of the practice by federal agencies, and the first thing they are going to ask you for is a copy of your last annual risk assessment.

Small practices may be targets of breaches too:

Many small practices think that they are too small to be targeted.   False again!   If you look at the HHS "Wall of Shame" which lists reported breaches of more than 500 patient records, you will see several small practices listed there who have undergone breaches.   The reality is that smaller practices are likely to be even more affected by a breach considering the high expenses and workload that follow.    The Ponemon Institute has calculated the average healthcare data breach cost to be $380 per record - for 500 records, that comes to approximately $190,000, which can be highly damaging for a small healthcare practice.

 

We often hear from dentists that they do not believe they need to comply.   Also False!  In fact, just recently, on January 2018, Steven Yang, DDS of California and Zachary Adkins, DDS of New Mexico had breaches of 3000+ patient records each due to the theft of a laptop and other portable electronic devices respectively.   

 

Robert Smith, DMD of Tennessee reported 1500 records breached after a hack.  Several other providers such as physicians, hospitals, pharmacies, health plans, and business associates have experienced breaches in the recent past.   It can and will happen to anyone regardless of size - please do not think that it won't happen to you!

Culture of Security and Privacy:

HIPAA Training is not HIPAA Compliance.   Practices should take these requirements seriously as they are here to protect patients and medical professionals.   Protect yourself and your patients by incorporating a culture of security and privacy compliance in your medical practice.

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HIPAA compliance tips for small medical practices

HIPAA compliance tips for small medical practices | HIPAA Compliance for Medical Practices | Scoop.it

But data breaches don’t just affect large corporate entities, they affect small healthcare organizations as well. Take the case of Holland Eye Laser Surgery in March 2018. Their five-provider group practice saw a data breach which made available the patient records of 42,000 patients. Hackers were able to access Social Security numbers, birth records, and other sensitive protected health information (PHI).

 

In fact, some of the medical records of these patients were sold off by data hackers. Officials from the practice stated that they’re now working to strengthening their security system. But once patient trust is lost, sometimes it just cannot be restored.

 

Brief primer on HIPAA and data breaches

• The Privacy Rule protects individually identifiable health information held or transmitted by a covered entity or its business associate, in any form, whether electronic, paper, or verbal

• Each entity must analyze the risks to e-PHI in its environment and create solutions appropriate for its own situation.

• The HIPAA Breach Notification Rule requires providers to notify affected individuals, HHS, and in some cases, the media of a breach of unsecured PHI. Most notifications must be provided without delay and no later than 60 days following the discovery of a breach.

 

5 tips to help you and your medical staff to avoid data breaches

1. CMS requires organizations to “[i]mplement policies and procedures to prevent, detect, contain, and correct security violations.” (45 C.F.R. § 164.308(a)(1).) Conduct a detailed risk analysis to evaluate the current staff and product deficiencies and create corrective measures.

2. Designate a staff member to train employees on your practice’s HIPAA policies and procedures and spend time going over typical breaches.

3. Hire an outside expert to help your organization with compliance support. Your outside organization should set up monthly meetings with the business owners to evaluate your company compliance program and work with your organization to identify cost-effective resources to keep your company compliant.

4. Customize your internet toolbars with anti-phishing protection. These applications can run website checks and compare them to lists of known phishing sites and alert users.

5. Be suspicious of any email message that asks you to enter or verify personal information through a website or by replying to the message itself.  Practice groups and or staff members should never reply to or click the links in such a messages.

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Five Steps to HIPAA Compliance for a Doctor's Office

Five Steps to HIPAA Compliance for a Doctor's Office | HIPAA Compliance for Medical Practices | Scoop.it

Why do you, as a doctor, dentist or any other medical provider, need to comply with HIPAA? HIPAA, the Health Insurance Portability and Accountability Act, was enacted by the US government to not only protect patient confidentiality and privacy but also to ensure that doctors and other medical practices protect their data to prevent unauthorized persons and criminals from getting access to patients' confidential, private and financial information.

 

Patient health records called PHI (Protected Health Information) are a valuable commodity for criminals and sell for high prices in the black market.   Medical professionals must therefore strictly abide by HIPAA rules in order to avoid monetary fines, damage to their reputation, loss of their license(s), and even imprisonment. Over the last few years, we have been hearing of multiple instances of doctors, nurses and healthcare workers being jailed or fined hefty sums for HIPAA violations. The Office of Civil Rights (OCR) has concentrated on education and outreach and has also focused on enforcement of HIPAA law especially when a healthcare organization suffers a breach or is in violation of HIPAA law.

 

Professionals in the medical field have the moral and ethical responsibility to abide by laws that govern them and to provide the utmost care, which includes protecting the health information of each and every patient. This requires the ability to make logical decisions minute by minute, plus a great deal of patience, professionalism, and high standards related to HIPAA compliance to ensure protection of ALL health information… which includes the following steps:

 

1. Exercise Privacy in Your Office Everywhere

  • Give patients the privacy they deserve in your office whether it’s in the lobby or their patient room.
  • Minimize references to patients; it is best to call patients by first or last name only when directing them to their patient room.
  • Allow for a quiet, private space when talking with patients individually so only those intended for the information are the ones who hear it.
  • Never leave patient documents/files unattended or unsecured.
  • Always knock before entering patient rooms.
  • While accessing electronic PHI (ePHI), make sure that no unauthorized person can see the data on your screen or device.
  • Continuously enforce this culture of privacy with your staff.

2. Post Notice of Privacy Practices

  • Print notice of privacy practices and place it in a common and clearly visible area in your office, so that patients are openly provided with the privacy laws and information that strives to keep their care confidential.
  • If you have a website for your practice, then be sure to post a copy of the Notice of Privacy Practices prominently on your website.
  • Keep copies of the Notice of Privacy Practices available in case any of your patients asks for a copy.

3. Maintain and Follow Written Policies and Procedures

  • Develop a written policies and procedures manual for everyone in your practice to follow, to ensure patient privacy and security. The manual should also contain forms, notices, disclosures and step-by-step procedures for patient privacy notification and overall HIPAA compliance.
  • Your policies and procedures should be accessible to all staff.  Get attestations from your staff that they have read and will abide by your written policies and procedures.
  • Review your policies and procedures annually to ensure that they are still current, and review them with your staff every year after this review.
  • Review, and if needed update, your policies and procedures whenever there is a major change in your practice, for instance, a change in your EHR or key software used like anti-virus, data backup service or anything similar.

4. Train Your Team on HIPAA Do’s and Don’ts

  • Ensure that your employees go through HIPAA training every year.
  • Your employees should sign and acknowledge their awareness of these HIPAA policies and procedures.
  • Document training dates and employee names as proof that all your employees have been trained.
  • All healthcare providers - doctors, nurses, and all staff - should undergo annual HIPAA training.
  • Ensure that your Business Associates also undergo annual HIPAA training.

5. Conduct the Mandatory Annual HIPAA Security Risk Assessment

  • This mandatory HIPAA security risk assessment should be completed in order to analyze risks within the practice. Typically, a security risk assessment will check your office for compliance with the HIPAA Security Rule and the HIPAA Privacy Rule.   Your security risk assessment would involve reviewing in detail your technical safeguards, physical safeguards and administrative safeguards which are all key elements of the HIPAA Security Rule.
  • You can either do this annual assessment internally or hire a HIPAA expert to perform the assessment.
  • If any evaluated areas require remediation or follow-up, plans of action will have to be developed with timelines to address them.
  • Be sure to address your follow-up action items within a reasonable period of time.  About 3-4 months is often considered a reasonable time for most doctors' offices.  For instance, if you are using a straight-cut shredder, your report might ask you to procure a cross-cut shredder or shredding service to make your document disposal process more secure.
  • Know where your patients' Protected Health Information is - where it is stored on your EHR, where your data backups are kept, on which employees you or your employees store any PHI, where printed versions of PHI may be kept.
  • If you don't already have Business Associate Agreements with your vendors, you should arrange to get them immediately.  These are important legal documents where you can specify the roles and responsibilities of your vendors or business associates when it comes to handle your patients' protected health information that you are ultimately responsible for.
  • While disposing of anything that has PHI on it - in any format - use secure disposal techniques. Your security consultant can guide you on how to securely dispose of PHI on different media. 
  • Some of the action items may be very technical, for instance, it may recommend that you implement secure email or encrypt your storage devices, or that you may need to get a vulnerability assessment done. Your IT vendor or security vendor should be able to guide you in these situations.

 

Ultimately, medical facilities that do not stray from complying with current rules and laws that govern their care and practice will continue to have the best reputation and the best rapport with their patients. Enforcing the highest level of HIPAA compliance within your facility means that you understand the importance of protecting health information and providing continuity of care across the medical spectrum to provide the best care outcomes for each and every patient in every way possible.

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10 Best Practices for HIPAA Compliance 

10 Best Practices for HIPAA Compliance  | HIPAA Compliance for Medical Practices | Scoop.it

A failure to understand HIPAA requirements can be a very costly mistake, as CardioNet learned just a couple months ago. In April, the wireless health services provider agreed to a settlement of $2.5 million for a potential noncompliance with the HIPAA Privacy and Security Rules. (1) The violation occurred when a company laptop containing the ePHI of 1,391 individuals was stolen from an employee’s vehicle parked outside their home. The Office for Civil Rights (OCR)’s investigation revealed that CardioNet had insufficient risk analysis and risk management processes in place at the time of the theft. In addition, the company’s policies and procedures implementing the standards of the HIPAA Security Rule were in draft form and had not been implemented. CardioNet was also unable to produce any final policies or procedures regarding the implementation of safeguards for ePHI, including those for mobile devices. 

 

“Mobile devices in the health care sector remain particularly vulnerable to theft and loss,” said Roger Severino, OCR Director. “Failure to implement mobile device security by Covered Entities and Business Associates puts individuals’ sensitive health information at risk. This disregard for security can result in a serious breach, which affects each individual whose information is left unprotected. 

 

Most HIPAA violations can be prevented by implementing HIPAA regulations into practice policies and procedures and ensuring all individuals with access to patient information receive the proper training. Below are ten best practices for keeping your practice HIPAA compliant.

 

10 Best Practices for HIPAA Compliance

  • Implement safeguards such as password protected authorization and encryption to access patient-specific information on all computers, laptops, and devices.
  • Practices should keep all patient paperwork, charts, and records locked away and safe out of the public's view. Never leave patient information out or unattended.
  • Computer programs containing patient information should be closed and logged out of when not in use. Never share passwords between employees.
  • Ensure all computers have updated anti-virus software installed. This will help keep a practice guarded against malicious software.
  • Limit emailing PHI if the information can be sent another way. When faxing PHI, always use a cover sheet.
  • Always properly dispose of information containing PHI by shredding paper files.
  • Make sure employees are aware that using social media to share patient information is considered a violation of HIPAA law.
  • If patient information is being accessed at home, ensure all home computers and laptops are password protected.
  • Back up all disks that contain PHI. Store patients’ information in a HIPAA compliant cloud server.
  • Compliance training is one of the simplest ways to avoid a violation. Practices should provide ongoing, up-to-date training on the handling of PHI for all employees.
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Recent Ransomware Attacks Could be HIPAA Violations

Recent Ransomware Attacks Could be HIPAA Violations | HIPAA Compliance for Medical Practices | Scoop.it
By now, you may have heard about the massive ransomware attack that has struck over 150 countries, including The United States, over the past week.
 
If health care data taken hostage in a ransomware attack is unencrypted, it could constitute a HIPAA violation. Any electronic protected health information (ePHI) that is affected by a breach without proper encryption methods in place is very likely to be compromised in the event of a ransomware attack.
 
These recent attacks come out of a growing trend in malware incidents over the past year. OCR has released guidance about how to handle a ransomware incident in your health care practice. The federal government has stressed the importance of safeguarding your organization and protecting your confidential patient data.
 
 
If you’re interested in protecting your organization from a ransomware incident–and want education about how to prevent ransomware attacks from spawning HIPAA breaches and fines–attend the upcoming webinar.
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HIPAA liability protections: business associate agreements are must for effective risk management

HIPAA liability protections: business associate agreements are must for effective risk management | HIPAA Compliance for Medical Practices | Scoop.it

The first step for a physician, known under the language of HIPAA as a “covered entity,” is to determine the need for a BAA with a vendor. A vendor is considered a “business associate” under HIPAA if the vendor creates, receives, maintains, or transmits patient health information (PHI) on the provider’s behalf.

 

Common services performed by a business associate (BA) include claims processing, data analysis, quality assurance, billing and collection, practice management, legal, accounting, and consulting.

 

Entities that only serve as conduits, such as the post office or Internet service providers, are not considered BAs even though they handle patient information.

 

What BAs must include

If a business associate is providing services to a covered entity, the parties must enter into a written BAA that:

 

  • establishes the permitted uses/disclosures of PHI,
  • stipulates that the BA must use appropriate safeguards to prevent unauthorized PHI uses and disclosures,
  • spells out that the BA reports to the covered entity any unauthorized uses and disclosures,
  • extends the terms of the BAA to its subcontracts, and
  • establishes that upon termination of the BAA, the vendor must either return or destroy all PHI.

 

The consequences of not having a written BAA can be severe. The Office of Civil Rights (OCR) could request a copy of a covered entity’s BAA if there is a complaint registered over a covered entity or if a breach occurs.

 

Violations under HIPAA can be penalized at anywhere between $100 to $50,000 per violation, up to a calendar year maximum penalty of $1,500,000 for a single violation. The OCR could take the position that every day that the BA and covered entity did not have a business associate agreement is a violation, and multiply the fine by the number of days no BAA penalty was in place, so the penalties can be steep.

 

Liability of agents

Under HIPAA, a covered entity is liable for the acts of its agents, which can include a BA.

 

Whether an agency relationship exists is determined case by case, with the essential factor being whether the provider has the right or authority to control the BA’s conduct. The authority of a provider to give instructions or directions is the control that can result in an agency relationship.

 

The language in the BAA will be considered in determining whether an agency relationship is present. If a covered entity is controlling the performance of its BA, the covered entity should closely monitor the BA’s performance since the covered entity will be held accountable for its performance.

 

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Legislation Changes and New HIPAA Regulations

Legislation Changes and New HIPAA Regulations | HIPAA Compliance for Medical Practices | Scoop.it

The policy of two out for every new regulation introduced means there are likely to be few, if any, new HIPAA regulations in 2018. However, that does not mean it will be all quiet on the HIPAA front. HHS’ Office for Civil Rights (OCR) director Roger Severino has indicated there are some HIPAA changes under consideration.

 

OCR is planning on removing some of the outdated and labor-intensive elements of HIPAA that provide little benefit to patients, although before HIPAA changes are made, OCR will seek feedback from healthcare industry stakeholders.

 

As with previous updates, OCR will submit notices of proposed rulemaking and will seek comment on the proposed changes. Those comments will be carefully considered before any HIPAA changes are made.

 

The full list of proposed changes to the HIPAA Privacy Rule have not been made public, although Severino did provide some insight into what can be expected in 2018 at a recent HIPAA summit in Virginia.

 

Severino explained there were three possible changes to HIPAA regulations in 2018, the first relates to enforcement of HIPAA Rules by OCR.

 

Since the introduction of the Enforcement Rule, OCR has had the power to financially penalize HIPAA covered entities that are discovered to have violated HIPAA Rules or not put sufficient effort into compliance. Since the incorporation of HITECH Act into HIPAA in 2009, OCR has been permitted to retain a proportion of the settlements and CMPs it collects through its enforcement actions. Those funds are used, in part, to cover the cost of future enforcement actions and to provide restitution to victims. To date, OCR has not done the latter.

 

OCR is considering requesting information on how a proportion of the settlements and civil monetary penalties it collects can be directed to the victims of healthcare data breaches and HIPAA violations.

 

One area of bureaucracy that OCR is considering changing is the requirement for covered entities to retain signed forms from patients confirming they have received a copy of the covered entity’s notice of privacy practices. In many cases, the forms are signed by patients who just want to see a doctor. The forms are not actually read.

 

One potential change is to remove the requirement to obtain and store signed forms and instead to inform patients of privacy practices via a notice in a prominent place within the covered entity’s facilities.

 

Severino also said OCR is considering changing HIPAA regulations in 2018 relating to good faith disclosures of PHI. OCR is considering formally clarifying that disclosing PHI in certain circumstances is permitted without first obtaining consent from patients – The sharing of PHI with family members and close friends when a patient is incapacitated or in cases of opioid drug abuse for instance.

 

While HIPAA does permit healthcare providers to disclose PHI when a patient is in imminent harm, further rulemaking is required to cover good faith disclosures.

 

While these HIPAA changes are being considered, it could take until 2019 before they are implemented.

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Texas Expands HIPAA Privacy Laws to Bolster EHR Security

Texas Expands HIPAA Privacy Laws to Bolster EHR Security | HIPAA Compliance for Medical Practices | Scoop.it

Governor of Texas, Rick Perry, has signed a new law to give Texas residents even greater protection than required by the Health Insurance Portability and Accountability Act and has increased penalties for healthcare organizations that fail to implement the appropriate security measures to protect the health data of patients.

 

Under the Health Information Technology for Economic and Clinical Health Act (HITECH), covered entities have a number of responsibilities including reporting data breaches to the Office for Civil Rights (OCR). Data breaches are reportable to the OCR, either in an end of year report or after an investigation, depending on the number of individuals affected.

 

HIPAA places a number of restrictions on how ePHI is used and stored, and all covered entities are required to conduct a full risk analysis to assess systems for security vulnerabilities to allow risk to be managed. It also lays down the procedures that must be followed after a data breach, such as notifying potential victims. Covered organizations are also required to conduct an investigation into how a breach occurred as well as a risk of harm analysis.

 

One of the main aims of HIPAA has been to improve the standard of data security and protect the privacy of patients. HIPAA and HITECH can be seen as minimum standards that must be followed, and states are allowed to increase data security rules, provided that all HIPAA requirements are met.

 

Texas has now exercised the right to tighten state privacy laws to ensure electronic Protected Health Information is kept private and confidential.

 

Greater Protection for Texas Residents
The new Texas law follows HITECH, although it makes a number of amendments to further restrict the use of ePHI. The penalties have been increased for wrongful disclosure, breach notifications have been updated and healthcare organizations must provide more training to staff. A new requirement is that data privacy and security training must now be provided to employees every two years. Training courses must be documented and all attendees must sign to confirm that they have received training. A 60-day time restriction has also now applies for providing new employees with training.

 

According to the new law, “an individual’s PHI may not be disclosed without the patient’s authorization, except for purposes of treatment, payment, healthcare operations, insurance purposes, and as otherwise authorized by state or federal law”

 

Harsher Penalties for Wrongful Disclosure of ePHI
Failure to comply with the new legislation will result in increased financial penalties and possibly criminal penalties – the theft of ePHI is now considered a felony – being applied for the wrongful disclosure of ePHI. The state is also able to revoke both professional and institutional licenses. Financial penalties have been increased to a maximum of $250,000 for intentional disclosure of ePHI for financial gain, $25,000 for intentional or knowing violation and $5,000 for each individual negligent violation, although the maximum penalty for repeat offenders is $1.5 million and enforced withdrawal from Medicaid, the Children’s Health Insurance Program and other state funded healthcare initiatives is also a possibility.

 

When assessing violations, the seriousness of the data breach will be considered along with significant risk of harm, past history of the organization, certification, the efforts made to mitigate any damage caused and the amount necessary to deter the organization from allowing further violations to occur. Failure to issue breach notifications to affected individuals will also be penalized at a rate of $100 per day, per individual, up to a maximum fine of $250,000.

 

HIPAA regulations require employers to provide training on data Privacy and Security Rules, although this is only required within a short time frame of the commencement of employment and after a material change in Privacy and security policies. Under the new Texas law there is a requirement for ongoing training to be provided to staff and this must also be tailored to the employee’s position within the company. Rules have also changed on breach notifications to include all HIPAA covered entities including business associates, as well as non HIPAA-covered entities that wrongfully disclose ePHI.

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Do HIPAA Rules Create Barriers That Prevent Information Sharing?

Do HIPAA Rules Create Barriers That Prevent Information Sharing? | HIPAA Compliance for Medical Practices | Scoop.it

The HHS has drafted a Request for Information (RFI) to discover how HIPAA Rules are hampering patient information sharing and are making it difficult for healthcare providers to coordinate patient care.

 

HHS wants comments from the public and healthcare industry stakeholders on any provisions of HIPAA Rules which are discouraging or limiting coordinated care and case management among hospitals, physicians, patients, and payors.

 

The RFI is part of a new initiative, named Regulatory Sprint to Coordinated Care, the aim of which is to remove barriers that are preventing healthcare organizations from sharing patient information while retaining protections to ensure patient and data privacy are protected.

 

The comments received through the RFI will guide the HHS on how HIPAA can be improved, and which policies should be pursued in rulemaking to help the healthcare industry transition to coordinated, value-based health care.

 

The RFI was passed to the Office of Management and Budget for review on November 13, 2018. It is currently unclear when the RFI will be issued.

 

Certain provisions of HIPAA Rules are perceived to be barriers to information sharing. The American Hospital Association has spoken out about some of these issues and has urged the HHS to take action.

 

While there are certainly elements of HIPAA Rules that would benefit from an update to improve the sharing of patient health information, in some cases, healthcare organizations are confused about the restrictions HIPAA places on information sharing and the circumstances under which PHI can be shared with other entities without the need to obtain prior authorization from patients.

 

The feedback HHS is seeking will be used to assess what aspects of HIPAA are causing problems, whether there is scope to remove certain restrictions to facilitate information sharing, and areas of misunderstanding that call for further guidance to be issued on HIPAA Rules.

 

HIPAA does permit healthcare providers to share patients’ PHI with other healthcare providers for the purposes of treatment or healthcare operations without authorization from patients. However, there is some confusion about what constitutes treatment/healthcare operations in some cases, how best to share PHI, and when it is permissible to share PHI with entities other than healthcare providers. Simplification of HIPAA Rules could help in this regard, as could the creation of a safe harbor for good faith disclosures of PHI for the purposes of case management and care co-ordination.

 

While the HHS is keen to create an environment where patients’ health information can be shared more freely, the HHS has made it clear is that there will not be any changes made to the HIPAA Security Rule. Healthcare providers, health plans, and business associates of HIPAA-covered entities will still be required to implement controls to ensure risks to the confidentiality, integrity, and availability of protected health information are managed and reduced to a reasonable and acceptable level.

 

In addition to a general request for information, the HHS will specifically be seeking information on:

 

The methods of accounting of all disclosures of a patient’s protected health information
Patients’ acknowledgment of receipt of a providers’ notice of privacy practices


Creation of a safe harbor for good faith disclosures of PHI for purposes of care coordination or case management
Disclosures of protected health information without a patient’s authorization for treatment, payment, and health care operations
The minimum necessary standard/requirement.


While the RFI is likely to be issued, there are no guarantees that any of the comments submitted will result in HIPAA rule changes.

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