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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HIPAA/HITECH Act and Compliance

HIPAA/HITECH Act and Compliance | HIPAA Compliance for Medical Practices | Scoop.it

The Health Information Technology for Economic and Clinical Health Act (HITECH Act) legislation was created in 2009 to stimulate the adoption of electronic health records (EHR) and supporting technology in the United States. It introduced the Meaningful Use program incentivizing healthcare organizations to maintain the Protected Health Information of patients in electronic format, rather than in paper files.

 

Health Insurance Portability and Accountability Act (HIPAA), a Federal legislation that promulgated in 1996 requires the US Department of Health and Human Services (HHS) to develop national standards to protect the privacy and security of patients’ medical records and other personal health information. It got ratified in 2013 calling as the “Final Omnibus” rule, to include Enforcement and Civil Penalties.

 

HITECH and HIPAA, are separate and unrelated laws, but they do reinforce each other in certain ways. For example, HITECHrequires that any physician and hospital that attests to meaningful use must also have performed a HIPAA security risk assessment as outlined in the Omnibus rule.

 

Who does HIPAA affect?

According to HIPAA, if you belong to the category of “covered entities” or “business associates,” and you handle “protected health information (PHI),” you are required to be HIPAA-compliant.

1.Covered Entities:

  • Health Care Providers like Doctors, Surgeons, Dentists, Psychologists, Podiatrists, Laboratory technicians, Optometrists, Hospitals, Clinics, Nursing homes, organizations in the life sciences field such as medical devices, biotechnology, Pharmacies, schools when they enroll students in health plans, nonprofit organizations that provide some healthcare services, and even government agencies.
  • Health Plans like Health Insurance Companies, HMOs, Employer-Sponsored Health Plans, Government Programs like Medicare, Medicaid, Military and Veterans’ health programs.
  • Healthcare Clearing Houses. These are organizations that collect information from a healthcare entity, processes the data in an industry-standard format and delivers it to another entity. Examples of clearinghouses include: Billing services, Community health management information system.

2. Business Associates:

  • "Business associate” refers to any organization or individual who acts as a vendor or subcontractor with access to PHI.
  • Examples of business associates include: Data transmission providers, Data processing firms, Data storage or document shredding companies, Medical equipment companies, Consultants hired for audits, Electronic health information exchanges, External auditors or accountants, Medical transcription companies, Answering services, Data conversion and data analysis service providers, Law firms, Software vendors and consultants, Financial institutions (if engaging in accounts receivable or other functions extending beyond payment processing), ISPs, ASPs, Cloud vendors, Researchers (if performing HIPAA functions for a covered entity), etc.
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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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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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No Exception to HIPAA Privacy Rules, Nurse Learns

No Exception to HIPAA Privacy Rules, Nurse Learns | HIPAA Compliance for Medical Practices | Scoop.it

Ms. P, 45, was a nurse working in the cardiology department of a large hospital. Her duties were varied, and included, among other things, accessing patient medical records to review lab values and other diagnostic tests ordered by physicians, and writing progress notes in patients' charts.

When she was originally hired by the hospital, she was given a lecture from human resources about the importance of patient confidentiality. Ms. P was required to sign an agreement stating that she would protect patient confidentiality by only seeking or obtaining information regarding a patient that was required to perform her duties.

Later, when the U.S. Health Insurance Portability and Accountability Act (HIPAA) went into effect, Ms. P was required to go to another human resources seminar and sign a revised confidentiality agreement.

 

The revised agreement stated that she would not access or view information other than what was required to do her job, and that she would immediately ask her supervisor for clarification if she had any questions about whether information was required for her job.

 

Finally, the agreement contained a section saying that Ms. P acknowledged that violation of the facility's confidentially policy could result in disciplinary action up to and including termination.

Ms. P understood the importance of patient confidentiality and would never look in the records of patients that weren't hers—with two exceptions. Ms. P's mother and sister both had serious chronic conditions that frequently resulted in hospital visits over the years.

 

Ms. P's mother had Parkinson's disease, was on numerous medications, and was prone to falls. Ms. P's older sister, who lived with her, had Down syndrome. Ms. P would periodically look up her mother's and sister's health records on the hospital computer to get information or to access their treatment plans. She didn't see anything wrong with this because it was her own family.

 

One of her colleagues, however, had noticed Ms. P looking at the records on more than one occasion, and anonymously reported her. The hospital's HIPAA compliance officer began an investigation that revealed that Ms. P had accessed her mother's charts on 44 separate occasions and her sister's charts on 28 occasions.

 

When the human resources director confronted her with the results of the investigation, Ms. P admitted that she had accessed the records, but that they were the records of her family members and therefore she didn't see anything wrong with it.

 

“Did you need to access information from their medical records in order to do your job as a clinical affiliate in the cardiology department?” the human resources director asked sternly.

“No,” Ms. P replied. “They were not cardiology patients.”

She was fired that day. Angered by the loss of her job, Ms. P sought the advice of an attorney to see if she could sue the hospital for wrongful termination. The attorney was skeptical.

“HIPAA violations are taken very seriously,” he said. “Did they give you training about patient privacy?”

 

Ms. P admitted that she'd had training.

“Were you asked to sign anything?” the attorney inquired.

“Well, yes,” Ms. P said. “I did sign a confidentiality agreement, and the hospital does have a policy that you could lose your job for violating it. But this was my mother and sister! They don't mind that I looked at their records!”

 

“That's irrelevant,” the attorney said. “It doesn't matter if they are family or not. You still didn't have the right to look at the records. I don't think we have a leg to stand on, unless…” the attorney trailed off, thinking.

 

“How old are you?” he suddenly asked.

When she told him, he smiled. “I think we may have an angle. We can try suing the hospital for age discrimination. We can claim that the privacy violation was merely a pretext to get rid of you – a higher paid experienced nurse – and replace you with a less expensive junior person.”

 

The attorney filed the papers against the hospital. The hospital's attorney promptly filed a motion to dismiss. The court, after reviewing all the facts, dismissed Ms. P's case.

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What Happens in HIPAA Audits: Breaking Down HIPAA Rules

What Happens in HIPAA Audits: Breaking Down HIPAA Rules | HIPAA Compliance for Medical Practices | Scoop.it

HIPAA audits are something that covered entities of all sizes must be prepared to potentially go through. As technology continues to evolve, facilities need to ensure that they are maintaining PHI security and understand how best to keep sensitive information secure.


The Department of Health & Human Services (HHS) Office for Civil Rights (OCR) had originally scheduled its second round of HIPAA audits for the fall of 2014, yet as of this publication, round two is still waiting to be scheduled. Regardless, HIPAA audits are an essential aspect to the HIPAA Privacy and Security Rules.


We’ll break down the finer points of the audit process and why it is important, while also highlighting tips for facilities in case they are selected for an OCR HIPAA audit.


What are the HIPAA audits?


The OCR HIPAA audit program was designed to analyze the processes, controls, and policies that selected covered entities have in place in relation to the HITECH Act audit mandate, according to the HHS website.

OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification. The combination of these multiple requirements may vary based on the type of covered entity selected for review.

The HIPAA audits also are designed to cover HIPAA Privacy Rule requirements in seven areas:

  • Notice of privacy practices for PHI
  • Rights to request privacy protection for PHI
  • Access of individuals to PHI
  • Administrative requirements
  • Uses and disclosures of PHI
  • Amendment of PHI
  • Accounting of disclosures.


Why are the HIPAA audits important?


HIPAA audits are not just a way for OCR to ensure that covered entities are keeping themselves HIPAA compliant. Having periodic reviews of audit logs can help healthcare facilities not only detect unauthorized access to patient information, but also provide forensic evidence during security investigations. Auditing also helps organizations track PHI disclosures, learn about new threats and intrusion attempts, and even help to determine the organization’s overall effectiveness of policies and user education.


In FY 2014 alone, the OCR resolved more than 15,000 complaints of alleged HIPAA violations, according to the national FY 2016 budget request proposal report.


“OCR conducted a pilot program to ensure that its audit functions could be performed in the most efficient and effective way, and in FY 2015 will continue designing, testing, and implementing its audit function to measure compliance with privacy, security, and breach notification requirements,” the report authors explained. “Audits are a proactive approach to evaluating and ensuring HIPAA privacy and security compliance.”


The HIPAA audits are important because they help incentivize covered entities to remain HIPAA compliant, but they are also an opportunity to strengthen up organization’s security measures and find any weak spots in their approach to security.


What if I am selected for the HIPAA audit program?


As previously mentioned, there is not yet an exact date for when the next round of HIPAA audits will take place, there have been several reports that preliminary surveys have been sent to covered entities that may be selected for audits.


According to a report in The National Law Review, OCR will audit approximately 150 of the 350 selected covered entities and 50 of the selected business associates for compliance with the Security Standards. Furthermore, OCR will audit 100 covered entities for compliance with the Privacy Standards and 100 covered entities for Breach Notification Standards compliance.


Whether your organization received one of those surveys or not, it’s important for entities to have at least a basic plan in place for potential audits. Healthcare organizations should not rely on a false sense of security, and they need to ensure that when their data systems and safeguards are being reviewed, that facilities try and keep in mind what the OCR would be looking for so no areas are missed.


Current physical safeguards, administrative safeguards, and technical safeguards are not only required by the Security Rule, but they work together to protect health information. In addition to those areas, here are a few key things for covered entities to maintain, as they may play a role in the HIPAA audit process:


  • Perform comprehensive and periodic risk analyses
  • Keep thorough inventories of business associates and their contracts or BAAs.
  • Maintain thorough accounts of where ePHI is stored, this includes but is not necessarily limited to internal databases, mobile devices and paper documents.
  • Thorough records of all security training that has taken place.
  • Documented evidence of the facility’s encryption capabilities.


If covered entities have performed a proper risk assessment, preparing for the HIPAA audits will not be as daunting. For further discussion on the legal implications of risk assessments and analyses.


Maintain compliance and stay prepared


Perhaps one of the best ways to prepare for a potential OCR HIPAA audit is to keep all three safeguards current, ensuring to adjust them as necessary as technology evolves.


It is also essential for covered entities to know their BAs, and have all appropriate contracts and business associate agreements in place and up to date.


Conducting periodic risk analysis will also be beneficial, and covered entities should be sure to be able to provide evidence of compliance. This can include documentation of policies and procedures being in place. For example, instances where a facility has sanctioned people and whether it was consistent with its sanctions policy will be beneficial if an audit takes place that looks at the sanction process.


Without a risk analysis, it is much more difficult for healthcare organizations to know where they are in terms of security. This can be detrimental not only for HIPAA audits, but also in maintaining comprehensive data security. Periodic reviews will help facilities continue to work toward maintaining HIPAA compliance and keeping sensitive data as secure as possible.

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HIPAA Regulations Create Communication Obstacle, Says Survey

HIPAA Regulations Create Communication Obstacle, Says Survey | HIPAA Compliance for Medical Practices | Scoop.it

HIPAA regulations are a necessity for covered entities, but if a recent survey is any indication, they could also be creating issues for providers.


The majority of surveyed providers – 61 percent – stated that HIPAA regulations pose an obstacle to communication and collaboration within the care team, according to a PerfectServe survey. However, respondents also indicated that working to improve secure communications was a goal for their organization. Specifically, 83 percent said that secure communication was a top priority, while 69 percent stated that they already have several applications and technologies in place.


The survey was conducted online by the Harris Poll, on behalf of PerfectServe. A total of 955 doctors, nurses, case managers and healthcare administrators were interviewed, the majority of which – 65 percent – were in hospital-based practices. Thirty-five percent of respondents worked in an office-based organization or a private practice.

The survey also showed the provider-patient communication breakdown, finding that the majority of respondents use follow-up phone calls with patient and online patient portals to communicate with patients. The most common methods of communication are below:


  • 83 percent of respondents use follow-up patient calls
  • 74 percent of those surveyed utilize online patient portals
  • 46 percent use a unified communication platform
  • 41 percent of respondents use patient text reminders/updates
  • 39 percent engage in telemedicine


In terms of patient care, respondents stated that communication breakdowns often hinder their ability to properly care for patients. Seventy-one percent of physicians, specialists, and hospitalists said they either strongly agree or agree that they have wasted valuable time when trying to communicate with the broader care team. Moreover, 71 percent of nurses and case managers said that time is often wasted when they try to communicate with the right physician for a particular situation.


The majority of respondents – 69 percent – also stated that patient care is often delayed while waiting for important information about the patient, while 67 percent of those surveyed admitted that they often receive pages or calls that low priority and disrupt patient care.

A unified communication system could potentially be the answer to some of those issues, according to the survey. Of the 29 percent who stated that they are not satisfied with the secure technology utilized by their organization, 68 percent explained that the dissatisfaction largely arises because different members of the community use different technologies. Moreover, 55 percent of those who were dissatisfied said that not all team members have access to secure communication technology.


Similar results were found in a recent Peak10 survey, where C-level executives and information technology professionals were interviewed. In that report, 60 percent of respondents said that government mandates are having a negative effect on their industry, while 94 percent said complying with regulations influences IT strategy and decision-making.


Additionally, 70 percent of respondents said that in terms of healthcare security, they need partners to assist with those concerns, along with data privacy issues.


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HIPAA breach puts blame on business associate

HIPAA breach puts blame on business associate | HIPAA Compliance for Medical Practices | Scoop.it

A New York healthcare provider is notifying its patients that their medical data has been compromised after one of its business associates reported the theft of an employee-owned laptop and unencrypted smartphone.    The New York-based Senior Health Partners, part of the Healthfirst health plan, has mailed out breach notification letters to 2,700 of its members after discovering that a laptop and mobile phone belonging to a registered nurse employed by its business associates were reported stolen.    Officials say the nurse's laptop, which was stolen back on Nov. 26, was encrypted, but the encryption key was in the laptop bag that was taken. The mobile phone stolen was neither encrypted nor password-protected. The nurse was employed by Senior Health Partners' business associated with Premier Home Health, which notified the long-term care provider on Dec. 10. Affected patients were mailed notification letters Jan. 30.    An investigation into the theft found that the privately-owned laptop included a "potentially accessible" email, containing patient names, demographics, Social Security numbers, Medicaid IDs, dates of birth, clinical diagnoses and treatment information and health insurance claim numbers. "Senior Health Partners sincerely regrets that this incident occurred," read a Jan. 30 press statement. "It takes the privacy and security of members' health information very seriously and expects its vendors to do the same. SHP values the trust its members have placed in it as their health plan, and it is SHP's priority to reassure its members that it is taking steps to ensure its members' information is protected."   Asked what Senior Health Partners' policy was around encryption and using privately owned devices for work purposes, Healthcare IT News did not receive a response before publication time.    To date, nearly 42 million individuals have had their protected health information compromised in a reportable HIPAA privacy or security breach, according to data from the Department of Health and Human Services.


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Why Healthcare Providers Need to Take HIPAA Risk Assessments Seriously

Why Healthcare Providers Need to Take HIPAA Risk Assessments Seriously | HIPAA Compliance for Medical Practices | Scoop.it

Whether your organization falls under HIPAA, FISMA or PCI DSS you need to do a risk assessment. Yes it’s a good thing to do self-assessment but in order to prepare for a full compliance audit it’s important to get an independent outside consultant to perform this critical assessment.

I have worked in and audited many organizations that all too often wanted to do the minimum and were completely unaware of their full responsibility to meet their compliance. They also in many cases did not have the internal staff or expertise to do a high quality assessment.

[ Three simple steps to determine risk tolerance ]

To begin, let’s look at HIPAA. From hhs.gov, The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of the U.S. Department of Health and Human Services (HHS) to develop regulations protecting the privacy and security of certain health information. To fulfill this requirement, HHS published what are commonly known as the HIPAA Privacy Rule and the HIPAA Security Rule.

The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information. The Security Rule still focuses on individual’s health records but specifically focuses on ePHI, Electronic protected health Information. Under the Security Rule, covered entities are required to evaluate risks and vulnerabilities in their environments and to implement security controls to address those risks and vulnerabilities.

Let’s define compliance vs security. As I recently stated in a quote I made in the Nov 17 issue of Fortune, “How Frank Blake kept his legacy from being hacked”, “Compliance is backward-looking and static, security is forward-looking, dynamic, and intelligent.” Compliance is the foundation for security, it’s the minimum.

You can’t be secure if you are not compliant! A risk assessment will achieve compliance and actually make your organization more secure. The HIPAA Risk Assessment is required by law for HIPAA compliance, it’s not optional.
NIST 800-66 Appendix E Risk Assessment Guidelines

Scope the assessment. Where is the ePHI? Servers, Workstations, smartphones, Laptops, backups, cloud backup?
Gather information. The conditions which ePHI is created, received, maintained, processed or transmitted.
Identify realistic threats.
Identify potential vulnerabilities. Save
Assess current security controls.
Determine the likelihood and the impact of a threat exercising a given vulnerability.
Determine the level of Risk.
Recommend security controls.
Document the risk assessment results.

I have worked in many technical roles as well as performed many compliance audits as a consultant; we keep seeing many of the same things. No physical access controls, no vulnerability management, no PEN testing, no data loss prevention on mobile devices, no backups or backups not tested or not encrypted, account management issues, weak passwords or no separation of duties just to name a few. Just take a look at the Verizon data breach investigations report, it states most attacks are not highly difficult. Why? Because they involve the things required by compliance and too many organizations are weak on compliance. Besides the HIPAA law, why do we need to do risk assessments?
The HIPAA Risk Assessment

From hhs.gov RISK ANALYSIS Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the [organization].

The following questions adapted from NIST Special Publication (SP) 800-66 are examples organizations could consider as part of a risk analysis. These sample questions are not prescriptive and merely identify issues an organization may wish to consider in implementing the Security Rule:

Have you identified the e-PHI within your organization? This includes e-PHI that you create, receive, maintain or transmit.
What are the external sources of e-PHI? For example, do vendors or consultants create, receive, maintain or transmit e-PHI?
What are the human, natural, and environmental threats to information systems that contain e-PHI?


Notice they leave some room for reality by stating the sample questions are not prescriptive but rather issues an organization might consider in implementing the Security Rule.

NIST 800-66 states it this way:

Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of EPHI held by the covered entity.

A risk assessment methodology, based on NIST SP 800-30, is included in Appendix E of this document.
Are there any prior risk assessments, audit comments, security requirements, and/or security test results?
Is there intelligence available from agencies, the Office of the Inspector General (OIG), the US-CERT, virus alerts, and/or vendors?
What are the current and planned controls?
Is the facility located in a region prone to any natural disasters, such as earthquakes, floods, or fires?
Has responsibility been assigned to check all hardware and software, including hardware and software used for remote access, to determine whether selected security settings are enabled?
Is there an analysis of current safeguards and their effectiveness relative to the identified risks?
Have all processes involving EPHI been considered, including creating, receiving, maintaining, and transmitting it?

There are too many documents and rules and regulations, so sorting it all out can be confusing, but to do the actual Risk Assessment you must look to NIST 800-66 Appendix E.

Summary

With the federal mandate to put more healthcare records online, data breach after data breach spanning healthcare, military, retailers, and universities have become common. One must ask the question, what’s the root cause?

According to Leon Rodriguez, Director Office Civil Rights, US department Health and Human Services, since the HITECH Act, HIPAA complaint traffic geometrically increased. In the last three years, there have been over 70,000 HIPAA violation complaints. Pre-HITECH, the maximum penalty per year per provision violated was $25,000. Now it’s $1.5 million.

Before the new rules, willful neglect had to be proven to pursue any type of penalty. Any lesser measure of culpability was not actionable through penalties. But consumers need confidence that there is an effective enforcement entity if they are going to feel comfortable being forthright in sharing sensitive health information. The HIPAA penalties applied were due to:

Failure to have adequate HIPAA compliance policies and procedures as administrative safeguards.
Failure to complete HIPAA security training for their staff.
Failure to implement access controls as physical safeguards.
Failure to encrypt the information on the device or an equivalent protection.

In 2009, the breach notification for unsecured protected health information was enacted, the U.S. Department of Health and Human Services' database of major breach reports (affecting 500 or more people) has tracked 944 incidents affecting personal information from about 30.1 million people. There are also many more incidents of smaller-scale breaches (less than 500 people per incident). In 2012, HHS received 21,194 reports of smaller breaches affecting 165,135 people, according to the department's most recent report to Congress. Similar numbers were reported in 2011. In all, data breaches cost the industry $5.6 billion each year, according to the Ponemon Institute.

It’s obvious that we are pushing more healthcare data out than we can possible safely secure. We see basic compliance failures across all industries. CEOs need to take the lead and put policies, and processes in place that assure that 100% of the compliance objectives are met, this includes the mandated HIPAA risk assessment (no matter how small the healthcare practice) and at that same time start focusing on proactive, intelligence driven security monitoring and response. We can no longer do some compliance or some security or work in silos, our adversaries are well organized and funded and will stop at nothing to take what we are unable to properly secure for their personal gain.

We must always remember that “we must think of every way our data can be compromised, while a cyber-criminal only needs to think of one!"

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HIPAA Audits Are Still on Hold

HIPAA Audits Are Still on Hold | HIPAA Compliance for Medical Practices | Scoop.it

`The unit of the Department of Health and Human Services that enforces HIPAA still has plenty of work to do before it can launch its long-promised next round of HIPAA compliance audits, as planned for this year.

The HHS Office for Civil Rights has yet to develop a revised protocol for conducting the audits, OCR Director Jocelyn Samuels revealed during a Jan. 13 media briefing.


Samuels declined to offer a timeline for when OCR plans to resume its HIPAA audits, which Samuels says will include covered entities as well as business associates, who are now directly liable for HIPAA compliance under the HIPAA Omnibus Rule.

Early in 2014, OCR officials said the agency expected to resume compliance audits of covered entities in the fall of 2014, later expanding the program to include audits of business associates based on those vendors identified by covered entities in pre-audit surveys.

Then in September, OCR officials said the audit launch was stalled because of a delay in the rollout of technology to collect audit-related documents from covered entities and business associates.

In her comments Jan. 13, Samuels did not offer an explanation for the prolonged delay in resumption of HIPAA audits.

"OCR is committed to implementing an effective audit program, and audits will be an important compliance tool for OCR," Samuels said. The audits "will enable OCR to identify best practices and proactively uncover risks and vulnerabilities, like our other enforcement tools, such as complaints and compliance reviews; provide a proactive and systematic means to assess and improve industry compliance; enhance industry awareness of compliance obligations; and enable OCR to target its outreach and technical assistance to identified problems and to offer tools to the industry for self-evaluation and prevention. Organizations should continue to monitor the OCR website for future announcements on the program."

In 2012, OCR conducted a pilot HIPAA audit program for 115 covered entities that was carried out by a contractor, the consulting firm KPMG. It also issued an audit protocol offering a detailed breakdown of what was reviewed. OCR is revising the protocol to reflect changes brought by the HIPAA Omnibus Rule.

Rules In the Works

In addition to the pending audits, other HIPAA-related activities under way at OCR for 2015 include:

  • A final version of a proposed rule HHS issued last January to permit certain covered entities, including state agencies, to disclose to the National Instant Criminal Background Check System the identities of persons prohibited by federal law from possessing or receiving a firearm for reasons related to mental health;
  • An advanced notice of proposed rulemaking related to a HITECH Act mandate for HHS to develop a methodology to distribute a percentage of monetary settlements and penalties collected by OCR to individuals affected by breaches and other HIPAA violations;
  • A possible request for additional public input on OCR's proposed accounting of disclosures rule making. Samuels says OCR is still evaluating the comments it received on the proposed accounting of disclosures rule it issued in 2011, as well as recommendations from the HIT Policy Committee about refining the rule.

In a statement provided to Information Security Media Group, Samuels noted, "The [accounting of disclosures] rulemaking is still listed as a long-term action on our last published regulatory agenda. We are exploring ways to further solicit public input on this important issue."

OCR in May 2011 issued a notice of proposed rulemaking for updating accounting of disclosures requirements under HIPAA. The proposal generated hundreds of complaints from healthcare providers and others. Many of the complaints were aimed at a controversial "access report" provision. As proposed, the access report would need to contain the date and time of access to electronic records, the name of the person or entity accessing protected health information, and a description of the information and user action, such as whether information was created, modified or deleted. The proposal would also provide patients with the right for an accounting of disclosures of electronic PHI made up to three years prior to the request.

Other Enforcement Activities

OCR also has a number of other enforcement activities planned for 2015, Samuels said in the Jan. 13 briefing.

"We will continue to identify and bring to resolution high impact cases that send strong enforcement messages to the industry about compliance," she said. "These types of cases can include the lack of a comprehensive risk analysis and risk management practices, ignoring identified threats and hazards to systems containing electronic protected health information, and insufficient policies and procedures, and training of workforce members."

OCR also expects to provide policy clarification for a variety of topics, including cloud computing and the "minimum necessary" rule, which HHS says is based on the premise that protected health information should only be used or disclosed if it is necessary to satisfy a particular purpose or carry out a function.

"We will also continue dialogues with our stakeholders about issues on which they would like additional interpretation," Samuels says.


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Employees could leave health systems vulnerable to hacks

Employees could leave health systems vulnerable to hacks | HIPAA Compliance for Medical Practices | Scoop.it

Healthcare organizations are vulnerable to cyberattacks in many ways, with a big threat being a company or hospital's own employees, according to Ari Baranoff, assistant special agent in charge for the U.S. Secret Service's Criminal Investigative Division.

"Your workforce is a potential vulnerability to your network," Baranoff tells Healthcare IT Security. "Constantly educating your workforce and testing your workforce on their cyberhygiene is very important."

Even if employees mean no harm, just by browsing the Internet or checking their email they can put networks at risk, Baranoff says. It's especially dangerous if these activities are done using the same system that houses electronic health records or other hospital information.

In addition, employee information is also something that often is at risk and can raise problems for hospitals. The Secret Service has seen growing interest in extortion and ransomware campaigns in the healthcare industry, according to Baranoff.

However, a great deal of the threats to health systems come from the outside world, he adds.

For instance, recent breach at Sony Pictures, the health information of employees was hacked, including a memo with treatment and diagnosis details about an employee's child with special needs, as well as a spreadsheet from a human resources folder containing birth dates, health conditions and medical costs.

Data breaches are expected to increase in 2015, with healthcare "a vulnerable and attractive target for cybercriminals," according to Experian's 2015 Data Breach Industry Forecast.

Electronic medical records and consumer-generated data from wearables and other devices will continue to add to the vulnerability and complexity in securing personal health information, according to the report.

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Former Kokomo dentist agrees to fine for violating HIPAA

Former Kokomo dentist agrees to fine for violating HIPAA | HIPAA Compliance for Medical Practices | Scoop.it

Former Kokomo dentist Joseph Beck agreed to pay the state $12,000 for disposing of patient files in an Indianapolis Dumpster, the Attorney General’s Office reported Friday.

The Attorney General’s Office sued Beck for failing to protect personal information and for improperly disposing of records containing personal information of Indiana residents, which violates state privacy laws as well as the federal Health Insurance Portability and Accountability Act (HIPAA). This is the first time Indiana has sued for a violation of HIPAA.

More than 60 boxes of patient records from Beck’s former Comfort Dental clinic in Kokomo were found discarded in an Indianapolis Dumpster in March of 2013. The files contained records from 2002-2007.

“In an era when online data breaches are top of mind, we may forget that hard-copy paper files, especially in a medical context, can contain highly sensitive information that is ripe for identity theft or other crimes,” Attorney General Greg Zoeller said in a news release.

“This file dump was an egregious violation of patient privacy and safety.”

Beck agreed to a consent judgment with the state, in which he will pay a $12,000 penalty for these violations. The order was signed this week in Marion County court.

In December of 2011, the Indiana Board of Dentistry permanently revoked Beck’s license to practice dentistry, following an investigation by the Attorney General’s Office that cited fraudulent billing and negligence, the news release stated.

In March of 2013, Beck hired private company Just the Connection, Inc. to retrieve and dispose of his patient records, which included names, medical records, phone numbers, birth dates, Social Security numbers, insurance cards, insurance information and state ID numbers.

The Attorney General said less than a week later, 63 boxes of patient records were found in a Dumpster at Olive Branch Christian Church on the south side of Indianapolis. The Attorney General’s Office recovered the files and fielded inquiries from individuals who were concerned that their records might be at risk. No identity theft was identified or reported.

Zoeller recently proposed new legislation that aims to prevent data breaches and identity theft, and reduce harm to potential victims. His proposed legislation would expand Indiana’s Disclosure of Security Breach Act to facilitate faster and more informative notification to consumers impacted by a breach. It also would add breaches of paper and handwritten records to the Act, as current law covers electronic records only.

Had the new legislation been in effect during this case, Beck could have faced increased penalties for improper data handling and disposal practices. It also would have enabled the state to hold Just the Connection, Inc. liable for the breach as well because Zoeller’s proposed legislation would cover “data collectors” in addition to “data owners.”

“The alarming rise in data breaches we’re experiencing on a global scale is putting countless Hoosiers at risk of identity theft, which can have absolutely devastating consequences,” Zoeller said. “Indiana’s laws must be updated to meet these crimes head on. The legislation I’ve proposed would close some loopholes in existing laws, and give the state more legal tools to combat irresponsible storage of personal or financial information, whether online or on paper."

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Tips For Reducing HIPAA Violation Risks

Tips For Reducing HIPAA Violation Risks | HIPAA Compliance for Medical Practices | Scoop.it

The need to attend to data security in increasing exponentially as enforcement tightens and the risk of significant financial penalties for HIPAA violations looms. To that end, a new white paper by Core Security provides some guidance for keeping data safe and avoiding risks of compromised patient information.

As Health IT Outcomes earlier noted, PwC report investigating the state of healthcare compliance found there is still much progress to be made in healthcare compliance across the board, and HIPAA privacy and security remain the top compliance concerns. Penalties for violations are increasing and reputations can be damaged, not to mention the imminent start of privacy audits from the HHS Office for Civil Rights. Compliance officers are challenged to fill gaps in their policies and procedures and be ready to demonstrate compliance with HIPAA requirements.

The cost of breaches can be crippling for healthcare organizations. For example, the OCR fined two health organizations almost $2 million in the wake of the theft of laptops, while Parkview Health paid out $800,000 in HIPAA fines and agreed to institute a corrective plan of action after it was alleged that the institution was dumping sensitive records.

These types of violations aren’t going away, either. A Redspin Breach Report found there was a 138 percent rise in the number of healthcare records breached in 2013, affecting some eight million records.

The Core Security whitepaper, Attack Intelligence: The Key To Reducing Risk in Healthcare, is designed to help healthcare institutions avoid these costly incidents. As the study asserts, “HIPAA-covered entities need to both identify their risks and take steps to mitigate that risk once they become aware of it.”

And yet, recent research demonstrates few healthcare industry professionals have a solid understanding of their own risks. A survey conducted by Healthcare Information Security found OCR audits have resulted in an increase in risk assessments, but that those assessments are often not complete. The data revealed 63 percent of respondents reported a data breach in 2014, and almost 50 percent acknowledged a data breach affecting a business partner. One contributing factor to these figures was that fewer than half of the 200 healthcare organizations surveyed had a documented risk assessment and risk management strategy in place and only 40 percent said they had one in the works.

While most healthcare organizations are cognizant of the need for basic security tools in assessing risk, the whitepaper asserts they do not provide the critical type of information necessary to manage risk – “actionable attack intelligence about sensitive IT assets like the medical record application servers or the backend databases that hold ePHI.”

“Healthcare organizations are familiar with risk management,” said Eric Cowperthwaite of Core Security, “But they aren’t necessarily thinking about how they’re going to be attacked. You may have a vulnerability management program. But the question is ‘How do you know which vulnerabilities matter? How do you know which possible attacks are likely – or not?’”


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HIPAA Privacy During Emergency Situations

A patient arrives at your facility with Ebola-like symptoms. After taking the necessary precautions, you run the requisite tests, conduct a patient interview, and determine that in fact the patient has contracted the Ebola virus. You also learn that the symptoms have been present for a couple of days, but like many people, the patient delayed seeking treatment until the symptoms got worse. After questioning the patient, you discover that since returning from West Africa one week earlier, the patient has returned to work, visited with family, attended church, and been shopping at the local mall, all while exhibiting symptoms. Thus, hundreds of people living in the community have potentially been exposed. What do you do? What information can you release to the public? Do you need the patient's consent to warn the public about the potential exposure?


The U.S. Department of Health and Human Services, Office for Civil Rights ("OCR"), the entity responsible for overseeing compliance with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), recently issued guidance on how to address HIPAA privacy in emergency situations, such as the one described above. Importantly, while there are a number of ways in which protected health information can be shared in an emergency situation, you should keep in mind that theprotections of HIPAA are not set aside during an emergency. Thus, while it is important to alert the public to the potential exposure, it must be done in a manner that is compliant with HIPAA. HIPAA, however, does provide several mechanisms through which information may be released...


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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 to Comply with HIPAA

How to Comply with HIPAA | HIPAA Compliance for Medical Practices | Scoop.it

The Health Insurance Portability and Accountability Act (HIPAA) was created in 1996 to protect patients' health information. Since its inception, health care providers have struggled with the need to protect patient privacy, share information, and keep paper work under control.


“When HIPAA came out, everyone was so afraid of penalties … but a lot of it was a reasonable recognition of patients' privacy that was already occurring in 99.9% of the cases,” said L. Lee Hamm, MD, Professor of Medicine and Executive Vice Dean at Tulane University School of Medicine in New Orleans.

 

“It added a lot of administrative burden and … it introduced a few things to make certain that people didn't inadvertently do something they shouldn't do.”

 

Electronic information


A part of HIPAA with which specialists in particular are concerned is sharing information among other health care providers. Entities covered under HIPAA are allowed to share private information with other health care professionals for the purposes of treatment, payment, and operations.

 

But Heinold said there are often delays during this process that can negatively impact quality of care and increase liability. This can occur when providers unnecessarily request patients' consent.

 

One of the most efficient ways to communicate among providers is via electronic communication. HIPAA was amended in 2009 to encompass the use of electronic health records with the Health Information Technology for Economic and Clinical Health (HITECH) Act.

 

Fresenius staff is increasingly receiving communication about patients electronically through mediums such as text and instant messaging, Heinold said. While this can facilitate exchange of records, it also comes with inherent risks. Fresenius trains staff to provide the minimum necessary information when texting about patients.

 

Louis Liou, MD, Chief of Urology at Cambridge Health Alliance, said his organization's biggest HIPAA concerns relate to electronic information. To comply, Cambridge ensures that all physicians with smart phones have them password protected and that their e-mail is secure.

 

Cambridge physicians try to avoid texting patient information when possible, but if they must, they do not use any patient identifiers in the text messages.

 

“There are a lot of pitfalls that could potentially happen,” Dr. Liou said. “Thumb drives have given way to Cloud issues. I think potentially there can always be problems – no matter how failsafe you make the system, there is always human error.”

 

Dialysis settings


Another concern is the communal open-floor nature of some clinical settings, as is often the case in dialysis centers, which may make it difficult to protect patient privacy. Still, training staff and implementing privacy procedures can go a long way to meeting HIPAA requirements.

 

Rosemary Heinold, Director of Communications for Fresenius Medical Care North America, a dialysis services provider and manufacturer of peritoneal and hemodialysis machines and equipment, said their organization has a handful of practices that help them comply with HIPAA.

 

Although patients are examined on the dialysis floor, Fresenius clinics also offer private examination rooms. Patients are never required to be examined in an open setting and may request a private room for physician consultations.

 

Like most providers, Fresenius staff gives patients a notice of privacy rights, which individuals must sign. They also post a notice of their privacy practices at all treatment sites.

 

Fresenius providers also work by the “minimum necessary” rule. The staff only shares the least amount of information necessary with patients on the clinic floor, particularly when others are within earshot.

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Six Potential HIPAA Threats for PHOs and Super Groups

Six Potential HIPAA Threats for PHOs and Super Groups | HIPAA Compliance for Medical Practices | Scoop.it

Physician Hospital Organizations (PHOs) and super groups are on the rise. About 40 percent of physicians either work for a hospital or a practice group owned by a hospital, or they ban together to form a super group. Individual practices share operations, billing, and other administrative functions, gain leverage with insurance companies, add specialist resources and increase referrals, improve patient outcomes with a cohesive care plan, and more. The benefits are plentiful.

But just like a negative restaurant review on Yelp can hurt customer patronage and the restaurant's reputation, one practice that commits a HIPAA violation can affect the entire group, and result in an expensive fine, cause distrust among patients, and in extreme cases, the data breach can lead to medical identity theft.


For PHOs and super groups, adherence to HIPAA rules becomes more complicated when compliance isn't consistent among the group's practices, and a compliance officer isn't on board to manage risks and respond to violations.


At a minimum, the group should identify the potential sources for exposure of electronic protected health information (ePHI) and take measures to avert them. For example:


Super groups include smaller practices that struggle with HIPAA compliance and associated time and costs. Although PHOs or super groups may be abundant in physicians, employees, and offices, these assets could come from a majority of smaller organizations. Historically smaller practices struggle with resources to comply with HIPAA and hiring expensive compliance consultants could be prohibitive at the individual practice level.


Each practice uses a different EHR, or the EHR is centralized but the ePHI is stored on different devices. It becomes difficult to assess HIPAA compliance as well as how patient data is being protected when there are various EHRs implemented across multiple practices. Some EHRs may be cloud based while other systems reside in an individual practice's office. Getting an accurate inventory of where ePHI is stored or accessed can be challenging.


Hospitals can't conduct thorough security risk assessments for each practice in the group. A PHO could have 20 or more individual practices and the time required to perform individual security risk assessments could be daunting. These risk assessments are labor intensive and could strain the resources of hospital compliance staff.


Meaningful use drives HIPAA compliance and grants from HHS could be significant, especially with a large number of providers. Along with these funds comes responsibility to comply with meaningful use objectives. One of the most frequent causes of failing a meaningful use audit is ignoring a HIPAA security risk assessment. If one practice fails an audit, it could open the door to other practices in the group being audited, which could result in a domino effect and a significant portion of EHR incentive funds having to be returned.


For physician groups that share patient information the security is only as strong as the weakest link — one practice or even one employee. A breach at one practice could expose patient information for many or all other practices. Security is then defined by the weakest link or the practice that has the weakest security implemented.


Untrained employees in the front office unwittingly violate HIPAA and a patient's right to privacy. An employee could fall for a phishing scam that gives criminals access to a practice's network, and compromises the security of many or all practices within the PHO or super group.


The best way to avoid a HIPAA violation and a patient data breach is to create a group policy that requires each practice to:


• Perform regular HIPAA security risk assessments;

 •Inventory location of patient information;

• Assess common threats;

• Identify additional security needs;

• Set up policies and procedures;

• Stay up to date on patient privacy rules and requisite patient forms; and

• Properly train employees in protecting both the privacy and security of ePHI.


Make sure every practice in the group treats HIPAA compliance with the same care as a patient's medical condition.

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Health Providers Beware: HIPAA Breaches May Give Rise To Negligence Actions

Health Providers Beware: HIPAA Breaches May Give Rise To Negligence Actions | HIPAA Compliance for Medical Practices | Scoop.it

Electronic medical records provide a multitude of benefits for providers and patients by promoting efficient record access, cost savings and better patient care.  So what's the down side?


Well, for starters, these records are ripe for hacking and inadvertent disclosures. As mentioned in a previous post, health care fraud has reached new heights by and through the theft of personal and medical information.  Left in the wrong hands, the sensitive information contained in these computerized records could unleash a fraud firestorm.


Historically, medical providers have successfully defended against claims brought by plaintiffs whose information was hacked or otherwise improperly accessed by relying upon the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") which expressly provides that there is no private right of action under HIPAA.  This success may be short lived as the number of hackers has increased and some courts, like Connecticut's Supreme Court,  have indicated a willingness to allow plaintiffs to bring claims for negligence and privacy violations against providers under state law.

HIPAA Standard of Care

In Byrne v. Avery Ctr. For Obstetrics & Gynecology, 314 Conn. 433 (2013), a health center produced a patient's protected health information (PHI) in response to a subpoena without notifying the patient and without taking any steps to protect it from disclosure in violation of HIPAA's guidelines.  The aggrieved patient filed an action against the provider for breach of contract, negligence, and negligent infliction of emotional distress.


While noting HIPAA's language with regard to private rights of action, the Court did not find that limitation dispositive of the negligence claim brought by the patient.  The Court hinted that a  violation of the standards promulgated under HIPAA may support a deviation from the standard of care required for a negligence claim.

Will New Jersey Follow Connecticut?

Given the proliferation of electronic medical records and the overwhelming amount of paperwork that healthcare providers deal with on a daily basis, the odds of falling victim to a HIPAA breach have markedly increased.  New Jersey health care providers should be mindful of the Connecticut case because New Jersey may follow this trend of reviewing HIPAA guidelines as a standard of care that may be considered to support a negligence action.

Problem Prevention
  1. Review and update HIPAA policies.
  2. Educate staff on the significance of the policies and demand 100% compliance.
  3. Develop a process to deal with subpoenas to ensure that the practice is in compliance with all applicable standards under federal and state law.


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Is your doctor's office the most dangerous place for data?

Is your doctor's office the most dangerous place for data? | HIPAA Compliance for Medical Practices | Scoop.it
Everyone worries about stolen credit cards or hacked bank accounts, but just visiting the doctor may put you at greater risk for identity fraud.

Those medical forms you give the receptionist and send to your health insurer provide fertile ground for criminals looking to steal your identity, since health care businesses can lag far behind banks and credit card companies in protecting sensitive information. The names, birthdates and — most importantly — Social Security numbers detailed on those forms can help hackers open fake credit lines, file false tax returns and create fake medical records.

"It's an entire profile of who you are," said Cynthia Larose, chair of the privacy and security practice at the law firm Mintz Levin in Boston. "It essentially allows someone to become you."

Social Security numbers were created to track the earnings history of workers in order to determine government benefits. Now, health care companies are, in some cases, required to collect the numbers by government agencies. They also use them because they are unique to every individual and more universal than other forms of identification like driver's licenses, said Dr. Ross Koppel, a University of Pennsylvania professor who researches health care information technology.

But once someone creates a stolen identity with a Social Security number, it can be hard to fix the damage. A person can call a bank to shut down a stolen credit card, but it's not as easy of a process when it comes to Social Security numbers.

"There is no such mechanism with Social Security numbers and our identity," said Avivah Litan, a cybersecurity analyst at the research firm Gartner. "You can't just call the bank and say, 'Give me all the money they stole from my identity.' There's no one to call."

So being that the data is so vital to protect, health care companies are taking every precaution to defend against hackers, right?

Not necessarily. The FBI warned health care companies a year ago that their industry was not doing enough to resist cyberattacks, especially compared with companies in the financial and retail sectors, according to Christopher Budd of security software company Trend Micro. The warning came in a government bulletin to U.S. companies that cited research by a nonprofit security institute, he said.

Last year, more than 10 million people in the U.S. were affected by health care data breaches — including hacking or accidents that exposed personal information, such as lost laptops — according to a government database that tracks incidents affecting at least 500 people. That was the worst year for health care hacking since 2011.

Litan estimates that the health care industry is generally about 10 years behind the financial services sector in terms of protecting consumer information. She figures that it may be twice as easy for hackers to get sensitive financial information out of a health care company compared with a bank. Banks, for instance, are more likely to encrypt personal data, which can garble the information if a hacker gets ahold of it. They also are much more likely to use advanced statistical models and behavior analytics programs that can spot when someone's credit card use suddenly spikes, says Litan, who studies fraud-detection technology. That's a sign of possible fraud that may be worth investigating.

"There's a need for that everywhere now," she said.

Health care companies do have security to protect sensitive patient information. Anthem, the nation's second-largest health insurer, said last week that hackers broke into a database storing information on 80 million people, including Social Security numbers. The company had "multiple layers of security" in place before the attack, said David Damato, managing director at FireEye, the security company hired by Anthem to investigate the breach.

But the stolen data was not encrypted. An Anthem spokeswoman said encryption wouldn't have helped, because the intruder used high-level security credentials to get into the company's system.

Still, several experts say encryption does help.

Encryption programs can be tuned so that even authorized users can view only one person's account, or a portion of an account record, at a time, said Martin Walter, senior director at cybersecurity firm RedSeal Networks. That makes it harder for an outsider to view or copy a whole stockpile of records.

Even if Anthem's security had proved invulnerable, the health care system offers several other inviting targets with varying levels of security. Hospitals, labs, clinics and doctor's offices all can be attacked. Cybersecurity experts say they expect even more health care hacking problems in the future as those layers of the health care system shift their paper files to electronic medical records, a push that has been boosted by federal funding in recent years.

"A lot of businesses that didn't place a premium on security are now placing this incredibly valuable information online," noted Al Pascual, director of fraud and security at the consulting firm Javelin Strategy & Research.

The experience of a big company like Anthem does not bode well for the broader health care industry, said Budd at Trend Micro.

"They have resources to throw at cyber security," he said. "And if someone with nearly unlimited resources can be breached like this, then it raises serious questions as to what's at risk."

Beth Knutsen still worries about someone using her Social Security number more than a year after she was told that some old patient files of hers had been taken from a doctor's office in Chicago. The 39-year-old New York resident visited that doctor nearly 20 years ago.

She's seen no signs of fraud yet, and she still provides her Social Security number when a doctor's office asks for it — but only because it seems to be required for insurance and billing.

"It's so scary," she said. "Who knows what can happen with that information?"
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Five common mistakes and how to avoid them for 2015 HIPAA audits

Five common mistakes and how to avoid them for 2015 HIPAA audits | HIPAA Compliance for Medical Practices | Scoop.it

2014 saw a rise in data breaches and HIPAA compliance failures within the healthcare industry. The Office for Civil Rights (OCR) takes privacy and security seriously, and more organizations have been fined for failure to comply with the Health Insurance Portability and Accountability Act (HIPAA). This year, the OCR will use the HIPAA audit program to randomly assess healthcare entities and business associates for compliance with the HIPAA privacy, security and breach notification rules. Here are five mistakes to avoid:  

  1. Failure to keep up with regulatory requirements

Gain a better understanding of specifications for standards as “required” versus “addressable.” Some covered entities must comply with every Security Rule standard. Covered entities must determine if the addressable section is reasonable after a risk assessment, and, if not, the Security Rule allows them to adopt an alternative measure. Be sure to document everything, particularly since the OCR may look at encryption with audits this year.  

  1. No documented security program

The OCR wants to know how you implement a security risk assessment program, so be sure your organization has a documented security awareness program. Once you know the requirements, assess your environment and your users. Does your organization have a security and compliance program in place? How well is it implemented? Who is involved? How often do you communicate? Everyone in your organization should be held responsible for ensuring the safety of data and following proper procedures. Have a plan and a point person in place, and ensure your compliance and security teams talk to each other. Create a committee with stakeholders and clear responsibility, and make sure the plan is documented, communicated and enforced across the organization.

  1. A reactive approach to audits

Once you establish a security program, proactively monitor security and performance indicators, as OCR audits will focus heavily on breach plans and the controls you have in place to protect them. Auditors will look for access to critical group memberships, so make sure you’re auditing and reporting on user activity – including your privileged users. Auditors are increasingly more interested in this area, due to the recent increase in insider incidents.

  1. Assumptions regarding business associates agreements

Contractors and subcontractors who process health insurance claims are liable for the protection of private patient information. Make sure you have an updated business associate agreement in place, and ensure the chain of responsibility is documented, agreed upon, and reviewed frequently by both parties. You can find sample contracts offered by the OCR to help you through this process. 

  1. A checkbox approach to compliance

Regulators want to discontinue the checkbox approach to compliance in favor of a risk-based security approach. Compliance and security must go hand-in-hand, and organizations will benefit from incorporating this mindset across both teams. Strong security measures make it easier to meet compliance regulations. By adopting an organizational self-discovery approach, you will have a higher level of visibility and awareness of internal issues, and achieve a more resilient business process and the next level of organizational maturity.


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How to Prepare for the Risk Assessment HIPAA Requires

How to Prepare for the Risk Assessment HIPAA Requires | HIPAA Compliance for Medical Practices | Scoop.it
My brother-in-law retired a few years ago after more than three decades in private practice. He ran his busy office the old fashioned way — without computers. His patients’ records were kept in manila folders filed in a wall of shelves. In longhand, his office manager recorded appointments in a big black book and kept track of accounts in a ledger tucked into a backroom drawer.

Today when I sat down to blog here about how to prepare for a risk analysis/risk assessment (the terms are interchangeable), I couldn’t help but think about my brother-in-law’s healthcare office and how its methods of dealing with patient information differed from most modern practices. I bring this up only to bring home an important point to keep in mind when setting out to do a risk assessment: Namely, no two healthcare practices have exactly the same information-system components, nor do they manage the flow of information in exactly the same way.

Performing a risk assessment regularly is a required component for HIPAA compliance — a do-it-yourself method of understanding where your healthcare practice might be vulnerable when it comes to keeping Protected Health Information (PHI and ePHI) safe. An intended by-product of a risk assessment is the development of plans and strategies within your office to prioritize and address those vulnerabilities.

Start here

It’s probably safe to say that, unlike my brother-in-law, you run an office that relies on information technology in a variety of ways. To prepare for a risk assessment, here’s what I suggest for you or whoever serves as the Security Officer in your practice: Catalogue the information-system components in the office that come in contact with PHI and ePHI and that play a role in either storing patient health information or transmitting it. Begin by listing:

Hardware – Computers at the front desk, tablets in clinical areas, printers, servers, scanners, modems, PDAs, and smartphones

Software — Operating systems; browsers; software for practice management, billing, EHR, email, and database and office productivity

Network components – Dedicated phone or cable lines, routers and hubs, firewall software and firewall hardware, wireless systems

Charting a course to HIPAA compliance

The next step is to create a simple chart to diagram and better understand how all that stuff works together in collecting, storing, and transmitting patient information. An at-a-glance depiction of the flow of information at your office.

This step is important because HIPAA requires that your assessment of risk be specific to your practice. A chart like this communicates, “This is how we do things here.” It’s also an effective way to get a handle on what needs to be updated and the places and intersections where breaches could occur.

Ready? Set? Assess!

With that flow chart in hand, you’ll have a head start on a thorough risk assessment. And here’s why that’s a good thing. In an online conversation at heathcarefosecurity.com, Verne Rinker, health information privacy specialist at the Office of Civil Rights (OCR), said this about the importance of risk assessment in healthcare practices:

“The number-one suggestion is risk analysis, and risk analysis needs to be comprehensive. It needs to look at all the systems because these are constantly changing as organizations change their IT infrastructure. It needs to be ongoing, which also catches not only the new systems that are coming online, but also catches changes in the existing systems and the existing business lines of entities. And it needs to be a regular part of their business. It needs to be on their corporate radar and in their culture of compliance.”

The topic of risk analysis/risk assessment is so important to HIPAA compliance, it deserves more than one blog. Stay tuned!
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IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its computers. The malicious programming breached the electronic protected health information (ePHI) of 2,743 individuals in violation of the Health Insurance Portability and Accountability Act (HIPAA).

The medical center was fined $150,000 and agreed to implement a corrective action plan for violating the mandates of HIPAA’s Security Rule. Under the Security Rule, covered entities and business associates must implement appropriate administrative, physical and technical safeguards to protect the confidentiality, integrity and security of ePHI.

According to OCR, the medical center adopted policies to comply with the HIPAA Security Rule, but failed to follow them after putting them to paper. The medical center did not perform an accurate or thorough risk assessment for ePHI, nor did it implement the necessary policies, procedures or technical security measures to prevent unauthorized access to ePHI. Specifically, OCR maintains that the medical center’s failure to identify and address basic risks — e.g., not regularly updating firewalls and running outdated, unsupported software — was the direct cause of the introduction of malicious software into its systems.

In addition to the monetary fine, the medical center agreed to implement a two-year corrective action plan requiring it to —

  • Revise, adopt and distribute updated Security Rule policies and procedures approved by OCR;
  • Develop and provide updated security awareness training — based on training materials approved by OCR — to employees, and update and repeat such training annually;
  • Conduct annual assessments of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI in its possession and document the security measures implemented to address those risks and vulnerabilities;
  • Investigate and report to OCR any violations of its Security Rule policies and procedures by employees; and
  • Submit annual reports to OCR describing its compliance with the corrective action plan.
  • OCR used its announcement to highlight the fact that HIPAA compliance is a continuous process and requires more than establishing initial policies, procedures and systems. Rather, covered entities and business associates will only be able to avoid expensive HIPAA fines and penalties by conducting regular ePHI risk assessments, addressing identified security vulnerabilities and regularly updating HIPAA policies and procedures.

Although technological safeguards are vital to keeping ePHI secure, human error is also a significant threat to patient data security and privacy, making a knowledgeable workforce crucial to HIPAA compliance. Covered entities and business associates can ensure HIPAA compliance with Thomson Reuters’ online training courses on HIPAA Privacy and Security and U.S. Data Privacy and Security. Our online compliance training courses explain the essential principles of HIPAA requirements and of safeguarding individuals’ personal information.


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N.J. Law Requires Insurers to Encrypt

N.J. Law Requires Insurers to Encrypt | HIPAA Compliance for Medical Practices | Scoop.it

A New Jersey law that will go into effect in July requires health insurers in the state to encrypt personal information that they store in their computers - a stronger requirement than what's included in HIPAA .

The new law, signed by N.J. governor Chris Christie last week, was triggered by a number of health data breaches in the state, including the 2013 Horizon Blue Cross Blue Shield of New Jersey breach affecting 840,000 individuals. That breach involved the theft of two unencrypted laptops.


The new law states: "Health insurance carriers shall not compile or maintain computerized records that include personal information, unless that information is secured by encryption or by any other method or technology rendering the information unreadable, undecipherable, or otherwise unusable by an unauthorized person.

The law applies to "end user computer systems" and computerized records transmitted across public networks. It notes that end-user computer systems include, for example, desktop computers, laptop computers, tablets or other mobile devices, or removable media.

Personal information covered by the encryption mandate includes individual's first name or first initial and last name linked with any one or more of the following data elements: Social Security number; driver's license number or State identification card number; address; and identifiable health information.

Different than HIPAA

"The New Jersey law differs from HIPAA in that it mandates implementing encryption, whereas HIPAA mandates addressing encryption," privacy attorney Adam Greene of law firm Davis Wright Tremaine says.

The Department of Health and Human Services offers this explanation of the HIPAA encryption requirement on its website: "The encryption implementation specification is addressable, and must therefore be implemented if, after a risk assessment, the entity has determined that the specification is a reasonable and appropriate safeguard in its risk management of the confidentiality, integrity and availability of electronic PHI.

"If the entity decides that the addressable implementation specification is not reasonable and appropriate, it must document that determination and implement an equivalent alternative measure, presuming that the alternative is reasonable and appropriate. If the standard can otherwise be met, the covered entity may choose to not implement the implementation specification or any equivalent alternative measure and document the rationale for this decision."

Greene points out that because the new state law is tougher than HIPAA, "A New Jersey health plan could determine that some of its protected health information does not require encryption under HIPAA, but they will nevertheless be required to encrypt the information under the New Jersey law."


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Indiana Attorney General Enforces HIPAA For First Time – Another Lesson for Small Business | The National Law Review

Indiana Attorney General Enforces HIPAA For First Time – Another Lesson for Small Business | The National Law Review | HIPAA Compliance for Medical Practices | Scoop.it

As we reported, state Attorneys General have authority to enforce the privacy and security regulations under the Health Insurance Portability and Accountability Act (HIPAA), pursuant to the authority granted under the Health Information Technology for Clinical and Economic Health (HITECH) Act. Shortly after announcing plans to seek legislation requiring stronger protections for personal and financial information, Indiana Attorney General Greg Zoeller reached a settlement with a dentist in his state, Joseph Beck, for improperly dumping patient records in violation of state law and HIPAA. The dentist agreed to pay $12,000 in fines.

According to news reports, over 60 boxes containing years of dental records pertaining to over 5,600 patients, and including very sensitive personal information, were found in a dumpster. Apparently, the dentist hired a third party vendor to dispose of the records; that vendor likely was a business associate under HIPAA and, if so, also subject to the HIPAA privacy and security rules.

For small medical or dental practices, as for other professional service businesses such as lawyers, accountants, and insurance brokers, data security can be both daunting and expensive if there is a breach. Like many businesses, small businesses rely on third party vendors to perform certain activities. When those activities involve personal information of the business’ customers, the business owner should be paying more attention. Ask the vendor about what steps it has in place to protect information, does it have a written information security plan, it is licensed, does it have insurance in the event of a breach, does it train employees about data security, and, yes, how does it dispose the records and data it is being asked to handle. In many states, businesses are required to have language in the service agreements with vendors about data security when the vendors are going to handle personal information. There is a similar provision under HIPAA for business associates.

It is troubling to see that sensitive records are still being found in dumpsters even after the many widely-publicized data breaches. But, as here, the owner of the records may not be able to avoid responsibility by shifting it to the vendor.


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How to create a hospital cybersecurity framework

How to create a hospital cybersecurity framework | HIPAA Compliance for Medical Practices | Scoop.it

As cybertattacks on the healthcare industry increase in intensity, hospitals and healthcare providers must establish a cybercentric framework.

For providers who don't have such a framework in place, Christopher Paidhrin, security administration and integrity manager in the compliance division of Pacific Northwest-based PeaceHealth, says it is important to do two things: Create a spreadsheet that can stimulate ideas and don't forget about business associates and vendors, including the flow of information into and out of the organization is imperative.

A good security risk template to consider is the National Institute of Standards and Technology's cybersecurity framework, he writes at HealthcareInfoSecurity.

Through his experience with cybersecurity, Paidhrin says he learned that being agile and proactive is very important, as is having early detection of threats and rapid response to attacks.

Providers, according to Paidhrin, should also start small: "Do something today that makes a difference tomorrow," he says.

In addition, he says organizations should communicate and pool their information to better help one another prepare for and prevent attacks.

NIST, in November, created draft guidelines to help organizations share information during and after a cyberattack.

"By sharing cyberthreat information, organizations can gain valuable insights about their adversaries," Christopher Johnson, lead author of the guidelines, says in an announcement. "They can learn the types of systems and information being targeted, the techniques used to gain access and indicators of compromise."

In addition,, the Health Information Trust Alliance says it will include privacy controls in version seven of its Common Security Framework.


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