Kusserow on Compliance: OCR enforcement update at the HCCA Compliance Institute

“OCR Enforcement Update” was the topic of the presentation by Iliana Peters, HHS Office for Civil Rights (OCR) Senior Adviser for HIPAA Compliance and Enforcement at the Health Care Compliance Association (HCCA) Compliance Institute. She provided an update on enforcement, current trends, and breach reporting statistics.  Peters stated that the OCR continues to receive and resolve complaints of Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191)  violations of an increasing number.  She cited that OCR has received 150,507 complaints to date, with 24,879 being resolved with corrective action measures or technical assistance.  At the rate of reports being received, the OCR is estimating receiving 17,000 complaints in 2017.  She said that this year OCR has placed a major priority on privacy issues and will be issuing guidance on this, ranging from social media privacy, certification of electronic health record technology, and the rationale for penalty assessment. She spoke about OCR’s Phase 2 audits that are underway, involving 166 covered entities (CEs) and 43 business associates (BAs). These audits are to ensure CEs’ and BAs’ compliance with the HIPAA Privacy, Security, and Breach Notification Rules that include mobile device compliance.  They address privacy, security, and breach notification audits. It is expected that among the results of this effort will be increases in  monetary penalties this year.  Phase 3 will follow the same general approach currently being used, which includes review of control rules for privacy protection, breach notification, and security management.

In her comments about what the OCR has learned from its audits and investigations, Peters made the point that most HIPAA breaches still commonly occur as a result of poor controls over systems containing protected health information (PHI). A particular vulnerability has been mobile devices, such as laptops computers, that failed to be properly protected with encryption and password.

OCR advice

 Peters provided in her slide presentation considerable advice as what CEs and BAs should do to prevent breaches and other HIPAA-related problems. CEs and BAs should:

  • ensure that changes in systems are updated or patched for HIPAA security;
  • determine what safeguards are in place;
  • review OCR guidance on ransomware and cloud computing;
  • conduct accurate and through assessments of potential PHI vulnerabilities;
  • review for proliferation of electronic PHI (ePHI) within an organization;
  • implement policies and procedures regarding appropriate access to ePHI;
  • establish controls to guard against unauthorized access;
  • implement policies concerning secure disposal of PHI and ePHI;
  • ensure disposal procedures for electronic devices or clearing, purging, or destruction;
  • screen appropriately everyone in the work area against the OIG’s List of Excluded Individuals and Entities (LEIE);
  • ensure departing employees’ access to PHI is revoked;
  • identify all ePHI created, maintained, received or transmitted by the organization;
  • review controls for PHI involving electronic health records (EHRs), billing systems, documents/spreadsheets, database systems, and all servers (web, fax, backup, Cloud, email, texting, etc.);
  • ensure security measures are sufficient to reduce risks and vulnerabilities;
  • investigate/resolve breaches or potential breaches identified in audits, evaluations, or reviews;
  • verify that corrective action measures were taken and controls are being followed;
  • ensure when transmitting ePHI that the information is encrypted;
  • ensure explicit policies and procedures for all controls implemented; and
  • review system patches, router and software, and anti-virus and malware software.

Expert tips to meet HIPAA compliance requirements

Carrie Kusserow, MA, CHC, CHPC, CCEP, is a HIPAA expert with over 20 years of compliance officer and consultant experience. She pointed out that the OCR finds that most HIPAA breaches still commonly occur as a result of poor or lapsed controls over systems with PHI.  She noted that Iliana Peters stated that the OCR often encounters situations where established internal controls were not followed; in many cases, discoveries of breaches within organizations were not promptly investigated.  Also, most of the breaches currently being reported involve mobile devices, specifically laptop computers, and a failure to properly encrypt and password protect PHI. Kusserow offered additional tips and suggestions to those offered in the OCR presentation, particularly as it relates to mobile devices.

  • Conduct a complete security risk analysis that addresses ePHI vulnerabilities.
  • Ensure the Code of Conduct covers reporting of HIPAA violations.
  • Validate effectiveness of internal controls, policies, and procedures.
  • Maintain an up-to-date list of BAs that includes contact information.
  • Ensure identified risks have been properly addressed with corrective action measures.
  • Develop corrective action plans to promptly address any weaknesses or breaches identified.
  • Follow the basics in prevention of information security risks and PHI breaches.
  • Ensure policies/procedures  govern receipt and removal of laptops containing ePHI.
  • Verify workforce member and user controls for gaining access to ePHI.
  • Verify laptops and other mobile devices are properly encrypted and password protected.
  • Implement safeguards to restrict access to unauthorized users.
  • Review adequacy of security processes to address potential ePHI risks and vulnerabilities.
  • Ensure the hotline is set up to receive HIPAA-related calls.
  • Verify that all BAs have signed business associate agreements.
  • Train the workforce on HIPAA policies/procedures, including reporting violations.
  • Investigate complaints, allegations, and reports of non-compliance promptly and thoroughly.
  • Engage outside experts to independently verify controls are adequate and being followed.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Covered entities should report cybersecurity threats, but no PHI disclosures

Cyber threats are becoming more and more common, both in general and specifically in the health sphere. The Department of Homeland Security operates the National Cybersecurity and Communications Integration Center (NCCIC), with four branches dedicated to protecting the right to privacy in the government, private sector, and international defense network communities. The US Computer Emergency Readiness Team (US-CERT) develops information on immediate threats and analyzes data gleaned from cybersecurity incidents.

As part of these efforts, health entities can report any suspicious activity or cybersecurity incidents to US-CERT. Disclosing cyber threat indicators, which includes information such as malicious reconnaissance, security vulnerabilities, methods of defeating controls or exploiting vulnerabilities, is intended to alert other entities of possible issues. This type of information sharing allows the federal government to better protect information systems, and maintain current alerts and reports on vulnerabilities on the US-CERT site.

HIPAA concerns

HHS recently clarified that entities subject to the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) may not disclose protected health information (PHI) for the purpose of sharing cyber threat indicators. This also applies to business associates. PHI may only be released under these circumstances if the disclosure is permitted under the Privacy Rule.

HHS noted that PHI is generally not included in cyber threat indicators, so prohibiting PHI disclosure in cyber threat reporting will typically not be an issue. Under the Privacy Rule, an entity could disclose PHI to law enforcement without the individual’s written authorization in order to comply with a court order or to alert and inform law enforcement as necessary regarding criminal activity. In some instances, an entity may report limited PHI. Entities may disclose to federal officials authorized to conduct national security activities or to protect the President. In all other circumstances that are not expressly included and permitted in the Privacy Rule, the entities must obtain authorization from the individual whose PHI is to be disclosed.

Protecting personal data beyond HIPAA

Safeguarding protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) is important, but what responsibilities do hospitals have to protect other types of personally identifiable information (PII)? What concrete steps can hospitals take to follow through on these responsibilities? Meg Grimaldi, Director of Compliance at Martin Luther King, Jr. Community Hospital in Los Angeles, and Sarah Bruno, Matthew Mills, and Jade Kelly, Partners at Arent Fox LLP, answered these questions in a Health Care Compliance Association (HCCA) webinar titled, “Navigating the Rest of the Iceberg: Privacy and Security Compliance Beyond HIPAA.”

Grimaldi began by reminding hospitals of the different types of information they encounter and the manner in which they encounter them. Aside from PHI gleaned through medical records, for example, hospitals may take in data used in accessing patient portals or submitted through event registrations and surveys. When gathering such information, hospitals must weigh the benefits of detriments of easy to use portals with the need to verity identity. User IDs, passwords, and personal questions are no longer sufficient to protect data; instead, hospitals should implement two-factor authentication—something a person knows, such as a User ID and password, with something a person has, such as a card or mobile device. Some hospitals may even consider utilizing biometrics. Hospitals should carefully consider the need to use cookies, which store data. If using cookies, session cookies are less risky because they do not save personal information beyond a single session. The use of long-term cookies must be carefully safeguarded.

The hospitals, themselves, may handle payment information or employee information submitted through secure portals, or may farm these duties out to third parties, but they remain no less responsible for the protection of the PII. Hospitals must ensure that business associate agreements (BAAs) or other contracts hold third parties accountable for handling types of data.

In general, hospitals should implement safeguards such as network segmentation, security scans, penetration testing, and encryption. In addition, they should routinely review software patching solutions, implement active alerts in intrusion detection systems, and periodically perform test backups. When data is no longer needed, hospitals should destroy it.

Bruno noted a need to categorize data as falling into the purview of specific laws, including HIPAA, the Children’s Online Privacy Protection Act of 1998 (COPPA) (P.L. 105-277), and various other federal and state laws, as well as industry standards. In addition, hospitals should take note that European countries accept a much broader definition of PII than the U.S., and that care should be taken the handling of information from European nationals. The hospital’s website should disclose its privacy practices. Mills discussed laws and industry standards that govern debtor data, including the Gramm-Leach-Bliley Act (GLBA), which requires financial institutions to provide their customers with notice of the institutions’ privacy practices and to safeguard sensitive data.

Kelly discussed hospitals responsibilities with respect to employee data, including noting in many cases that employee medical information should be kept separate from personnel files and accessed only by certain authorized individuals. Employer must also be sure to comply with the Fair Credit Reporting Act (15 USC § 1681 et seq.) and any applicable state laws.

Grimaldi discussed the need to inform employees of the location of PII policies and procedures and make sure they are easily accessible to employees. Hospitals should diversify training materials to discuss types of data beyond PHI so that they understand what must be protected. It is crucial for hospitals to use plain language, skipping jargon, abbreviations, and acronyms, to ensure that each employee understands what is being discussed. For example, many employees may understand the importance of not clicking on strange emails, but may not know that the tactic is referred to as “phishing” and may thus not understand directions about responses to phishing campaigns. It has been suggested that information needs to be communicated seven times before it is truly understood, so it is important to deliver information in various modes, including training, newsletters, and staff huddles. Hospitals should train employees in various social engineering techniques that are relevant to the particular organization.

Bruno noted that hospitals must create a culture in which employees feel comfortable letting the organization know about potential and actual breaches, which are inevitable, whether through a malicious hack or a lost laptop. Once a breach is identified, a number of individuals should be involved in the response, including the privacy officer, the head of marketing, and the chief information security officer (CISO).

OCR shows no signs of slowing HIPAA enforcement

The HHS Office for Civil Rights (OCR) is on pace to have another record-breaking year for enforcement actions against covered entities (CEs) and business associates (BAs) accused of Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) violations. As of February 13, 2017, it had already entered into two resolution agreements with CEs and imposed civil monetary penalties (CMPs) on another for only the third time in its history. Prior to 2016, the OCR had not entered into more than six resolution agreements with CEs or BAs in single year. As of December 2016, the OCR had entered into twice that number. As of February 13, 2016, the OCR had just imposed its second CMP, but had not yet entered into any resolution agreements.

The agency kicked off the year by entering into a $475,000 resolution agreement with Presence Health. Unlike past agreements that settled potential violations of the HIPAA Privacy and Security Rules, the Present Health resolution represented the OCR’s first agreement to resolve potential violations of the HIPAA Breach Notification Rule. Presence failed to notify the OCR, affected individuals, and the media that paper-based operating schedules containing the protected health information (PHI) of 836 individuals had gone missing in the statutorily-required 60-day timeline for breaches affecting more than 500 individuals; instead, it waited more than 100 days.

Eight days later, the OCR announced a $2.2 million resolution agreement with MAPFRE Life Insurance Company of Puerto Rico for Security Rule violations affecting the data of 2,209 individuals. The OCR determined that MAPFRE failed to perform a risk analysis, implement risk management plans, and encrypt data stored in removable storage media led to a breach caused when a thief stole a USB data storage device containing electronic PHI (ePHI).

In early February, the OCR announced that it had issued a final determination and imposed a $3.2 million CMP on Children’s Medical Center of Dallas due to a pattern of noncompliance with the Security rule. Children’s suffered a breach in 2010 due to the loss of an unencrypted, non-password-protected BlackBerry device containing the ePHI of 3,800 individuals.  It suffered a second breach in 2013; despite the first breach, Children’s had failed to encrypt a laptop containing the ePHI of 2,462 individuals that was later stolen. The agency determined that the CMP was merited based on Children’s failure to implement risk management plans, in contravention of prior recommendations to do so, and its failure to encrypt mobile devices, storage media, and workstations. The OCR also imposed CMPs against Lincare, Inc., a home health company, in 2016 and against Cignet Health in Prince George’s County, Maryland, in 2011.

The agency stepped up enforcement efforts in 2016, in part due to negative reports regarding its performance from the HHS OIG and the Government Accountability Office (GAO). It began the Phase 2 audit process, targeting both CEs and BAs, and announced its intention to allocate resources for the first time to investigate complaints of breaches affecting 500 individuals or fewer. It appears geared to continue, if not ramp up, its enforcement efforts, but the impact of newly appointed HHS Secretary Thomas E. Price, M.D.–who will appoint a new OCR director–remains to be seen. Price, a physician and former Congressional representative has historically opposed government regulatory activity of physicians. However, Adam H. Greene, Partner at Davis Wright Tremaine, suggests that, although Price the physician may dislike HIPAA, “his personal views will [not] necessarily lead to a significant change in enforcement.”