Press ReleaseThe U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit health system in southeast Texas.  Memorial Hermann agreed to pay $2.4 million and to comply with a corrective action plan after publicly disclosing a patient’s name in the title of a press release regarding an incident at one of its clinics.  In a week that has been filled with high-tech cybersecurity issues (see our recent blog posts on the WannaCry attack here and here), this settlement is a good reminder of HIPAA obligations unrelated to technology.

Continue Reading Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

It was a busy April for the Office for Civil Rights (“OCR”) (see our prior post on a settlement from earlier in April).  On April 20, OCR announced a Resolution Agreement with Center for Children’s Digestive Health, S.C. (“CCDH”) related to CCDH’s failure to enter into a business associate agreement with a paper medical records storage vendor.  The cost of that missing agreement?  $31,000.  Then, on April 24, OCR announced a settlement with CardioNet, a remote monitoring company for cardiac arrhythmias, related to CardioNet’s failure to implement compliant HIPAA policies and procedures and failure to conduct a sufficient risk assessment.  The price of those failures?  $2.5 million! Continue Reading Two HIPAA Mistakes Lead to Fines from OCR

Phishing Scam ImageEarlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam.  The phishing scam, carried out by accessing MCPN employees’ email accounts, gave a hacker access to the electronic protected health information (“ePHI”) of 3,200 individuals.  In investigating the breach, OCR determined that, prior to the breach, MCPN had not conducted a security risk analysis (a requirement under HIPAA).  Further, OCR found that even after MCPN conducted a risk analysis, its analysis was insufficient to meet the requirements of the HIPAA Security Rule.

In addition to the $400,000 fine, MCPN agreed to a corrective action plan with OCR.  That plan requires MCPN to conduct a comprehensive risk analysis and to submit a written report on the risk analysis to OCR.  Additionally, MCPN will be required to develop an organization-wide risk management plan, to review and revise its Security Rule policies and procedures, to review and revise its Security Rule training materials, and to report to OCR any instance of a workforce member failing to comply with its Security Rule policies and procedures. Continue Reading Gone Phishin’: Hack Leads to HIPAA Settlement

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.”  Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA enforcement trends as well as a road map to OCR’s current and future endeavors.

Continuing Enforcement Issues

Ms. Peters identified key ten enforcement issues that OCR continues to encounter through its enforcement of HIPAA. These issues include:

  1. Impermissible Disclosures. HIPAA’s Privacy Rule prohibits covered entities and business associates from disclosing PHI except as permitted or required under HIPAA. Impermissible disclosures identified by Ms. Peters all center on the need for authorization, and include:
    • Covered entities permitting news media to film individuals in their facilities prior to obtaining a patient’s authorization.
    • Covered entities publishing PHI on their website or on social media without an individual’s authorization.
    • Covered entities confirming that an individual is a patient and providing other PHI to reporters without an individual’s authorization.
    • Covered entities faxing PHI to an individual’s employer without the individual’s authorization.
  2. Lack of Business Associate Agreements. OCR continues to see covered entities failing to enter into business associate agreements.
  3. Incomplete or Inaccurate Risk Analysis. Under HIPAA’s Security Rule, covered entities are required to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic PHI (ePHI). According to Ms. Peters, organizations frequently underestimate the proliferation of ePHI throughout their environment, including into systems related to billing, faxing, backups, and medical devices, among others.
  4. Failure to manage identified risks. HIPAA requires regulated entities to put in place security measures to reduce risks and vulnerabilities. According to the presentation, several OCR breach investigations found that the causes of reported breaches were risks that had previously been identified in a risk analysis but were never mitigated. In some instances, encryption was included as part of the remediation plan, but was never implemented.
  5. Lack of transmission security. While not required in all cases, HIPAA does require that ePHI be encrypted whenever it is deemed appropriate. The presentation identified a number of applications in which encryption should be considered when transmitting ePHI, including email, texting, application sessions, file transmissions (e.g., FTP), remote backups, and remote access and support services (e.g., VPNs).
  6. Lack of Appropriate Auditing. HIPAA requires the implementation of mechanisms (whether hardware, software or procedural) that record and examine activity in systems containing ePHI. HIPAA-regulated entities are required to review audit records to determine if there should be additional investigation. The presentation highlighted certain activities that could warrant such additional investigation, including: access to PHI during non-business hours or during time off, access to an abnormally high number of records containing PHI, access to PHI of persons for which media interest exists, and access to PHI of employees.
  7. Patching of Software. The use of unpatched or unsupported software on systems which contain ePHI could introduce additional risk into an environment. Ms. Peters also pointed to other systems that should be monitored, including router and firewall firmware, anti-virus and anti-malware software, and multimedia and runtime environments (e.g., Adobe Flash, Java, etc.).
  8. Insider Threats. The presentation identifies insider threats as a continuing enforcement issue. Under HIPAA, organizations must implement policies and procedures to ensure that all members of its workforce have appropriate access to ePHI and to prevent those workforce members who do not have access from obtaining such access. Termination procedures should be put in place to ensure that access to PHI is revoked when a workforce member leaves.
  9. Disposal of PHI. HIPAA requires organizations to implement policies and procedures that ensure proper disposal of PHI. These procedures must guarantee that the media has been cleared, purged or destroyed consistent with NIST Special Publication 800-88: Guidelines for Media Sanitization.
  10. Insufficient Backup and Contingency Planning. Organizations are required to ensure that adequate contingency planning (including data backup and disaster recovery plans) is in place and would be effective when implemented in the event of an actual disaster or emergency situation. Organizations are required to periodically test their plans and revise as necessary.

Upcoming Guidance and FAQs

OCR also identified upcoming guidance and FAQs that it will use to address the following areas:

  • Privacy and security issues related to the Precision Medicine Initiative’s All of Us research program
  • Text messaging
  • Social media
  • Use of Certified EHR Technology (CEHRT) & compliance with HIPAA Security Rule (to be release with the Office of the National Coordinator for Health Information Technology (ONC))
  • The Resolution Agreement and Civil Monetary Penalty process
  • Updates of existing FAQs to account for the Omnibus Rule and other recent developments
  • The “minimum necessary” requirement

Long-term Regulatory Agenda

The presentation also identifies two long-term regulatory goals to implement certain provisions of the HITECH Act. One regulation will relate to providing individuals harmed by HIPAA violations with a percentage of any civil monetary penalties or settlements collected by OCR, while the second will implement a HITECH Act provision related to the accounting of disclosures of PHI.

Audit Program Status

The presentation discussed the current status of OCR’s audit program. As we have previously discussed, OCR is in the process of conducting desk audits of covered entities and business associates. These audits consist of a review of required HIPAA documentation that is submitted to OCR. According to Ms. Peters, OCR has conducted desk audits of 166 covered entities and 43 business associates. Ms. Peters also used the presentation to confirm that on-site audits of both covered entities and business associates will be conducted in 2017 after the desk audits are completed. We will continue to follow and report on developments in the audit program.

Commentary

The list of continuing enforcement issues provides covered entities and business associates with a helpful reminder of the compliance areas that are most likely to get them in compliance trouble. Some of the enforcement issues may require HIPAA-regulated entities to revisit decisions that they previously made as part of a risk analysis. Transmission security (#5, above) is an example of such an area that may warrant reexamination. In the past, encrypting data was often too expensive or too impracticable for many organizations. However the costs of encryption have decreased while it has become easier to implement. A covered entity or business associate that suffers a breach due to transmitting unencrypted PHI over the internet will likely garner little sympathy from OCR going forward. The presentation is also notable for the long list of guidance and FAQs that OCR will be publishing, as well as their plan to issue regulations to address changes ushered in by the HITECH Act that were not captured by the 2013 Omnibus Rule. These regulations, particularly the regulations related to accounting for disclosures of PHI, could have a far-reaching impact on how covered entities and business associates comply with HIPAA in the future.

As reported on the Privacy and Security Matters blog last week, the Mintz Levin privacy team recently updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws that we update on a quarterly basis, or more frequently as needed.  In addition to HIPAA, health care organizations must remain aware of the separate state notification obligations and other privacy and security laws when responding to data breaches. The Mintz Matrix is available here.

Continue Reading Mintz Matrix Updated with Amended State Data Breach Notification Laws in Five States

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143 individuals. The Resolution Agreement, which can be found here, also contains a detailed corrective action plan (CAP).

The Florida-based health system reported to OCR that the PHI had been impermissibly accessed by MHS employees and impermissibly disclosed to affiliated physician office staff. The PHI consisted of names, dates of birth, and social security numbers.

Continue Reading $5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.”  The original Common Rule had been in place for almost 30 years, with little change despite significant research and technology advances during that time.  Further change is on the horizon for the Common Rule, as the 21st Century Cures Act (Cures) includes a mandate for HHS and the Food and Drug Administration (FDA) to harmonize long-standing differences between the Common Rule and FDA Human Subject Protection regulations.    Continue Reading The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA.  Presence Health, a health care network in Illinois, discovered a breach of unsecured personal health information (PHI) on October 22, 2013.  After reporting the breach to OCR over three months later on January 31, 2014, OCR determined that Presence Health failed to notify OCR, each of the affected individuals, and prominent media outlets of the breach without unreasonable delay and within 60 days of learning of the breach, as required of Covered Entities under HIPAA. The violation resulted in a $475,000 settlement between OCR and Presence Health.

Continue Reading Recent HIPAA Enforcement Actions

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2 audit program. The email, which was disguised as an official communication, suggests that recipients click on a link. This link takes recipients to a non-governmental website marketing cybersecurity services.

On Wednesday, OCR followed up their alert with additional details about the phishing campaign. According to OCR, the phishing email originates from the email address OSOCRAudit@hhs-gov.us and directs individuals to a URL at http://www.hhs-gov.us. OCR points out the subtle difference from the official email address for its HIPAA audit program, OSOCRAudit@hhs.gov, noting that such subtlety is typical in phishing scams.

OCR also took the opportunity to confirm that it has notified select business associates of their inclusion in the Phase 2 HIPAA audits.  For more information about the Phase 2 audit program please visit our earlier post.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS letterhead under the signature of OCR’s Director Jocelyn Samuels and is being sent to HIPAA covered entities and their business associates.  The email prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program. When clicked, the link takes the recipient to a non-governmental website marketing a firm’s cybersecurity services. In its alert, HHS clarified that it is in no way associated with the firm.

Covered Entities and Business Associates should be aware of this email and should make their workforces aware of it.  This can also serve as an important reminder of the importance of being vigilant about phishing campaigns and not clicking links in any email that seems suspicious or unexpected.

While the firm’s specific claims of inclusion in the audit program are not based in fact, OCR’s audit program is itself quite real. This past July we discussed the audit letters that were sent to health care providers and health care clearinghouses alerting them to their inclusion in the audit. We also described how OCR would be auditing businesses associates during the fall season. Given that fall is upon us, it is now more critical than ever for business associates to review their compliance efforts.