In a dramatic turn, the US Department of Health and Human Services (HHS) has announced that effective immediately, penalties for many HIPAA violations will be subject to substantially reduced limits. After a record year of collecting high-dollar settlements, the agency has pulled back and tied its own hands through a Notification of Enforcement Discretion that will likely result in lower penalties and settlement agreement amounts.
Regulators provided key insights into enforcement trends and potential changes to HIPAA regulations at the 11th Annual “Safeguarding Health Information: Building Assurance Through HIPAA Security” conference in October co-hosted by the National Institute of Standards and Technology (NIST) and the Department of Health and Human Services (HHS), Office for Civil Rights (OCR).
After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone sensors, the New York Attorney General settled claims against three developers alleged to have engaged in “misleading” marketing claims and “irresponsible” privacy practices. Mobile health apps Cardiio and Runtastic claimed that their apps effectively and accurately measured heart rate after vigorous exercise using only a smartphone camera and sensors. The third, Matis, claimed that its app transformed a smartphone into a fetal heart monitor. Concerned that unregulated apps claiming to measure key vital signs and other health indicators may harm consumers if the apps provide inaccurate or misleading results, NY AG Eric Schneiderman brought enforcement actions against the trio of developers.
Representatives from government and the private sector discussed the present state of healthcare cybersecurity, and experts discussed practical strategies for implementing the HIPAA Security Rule at the ninth annual “Safeguarding Health Information: Building Assurance through HIPAA Security” conference held from October 19–20, 2016 and co-hosted by the National Institute of Standards and Technology and the Department of Health and Human Services, Office for Civil Rights. Comprehensive, enterprise-wide risk analysis and risk management practices remained points of emphasis throughout the conference. Additional themes, which we outline in this post, also emerged.
Cloud service providers are on notice: you are HIPAA business associates, even if you are unable to access the HIPAA protected information in your cloud. The Department of Health and Human Services Office for Civil Rights released guidance making clear that cloud service providers that create, receive, maintain, or transmit electronic protected health information are covered by HIPAA.
A new report from the Department of Health and Human Services Office of the National Coordinator for Health Information Technology highlights data protection gaps in the U.S. for health data from wearable devices, social media, and emerging technologies. The report, “Examining Oversight of the Privacy & Security of Health Data Collected by Entities Not Regulated by HIPAA,” identifies several areas in which privacy and security protections for health data have lagged behind technological developments that are expanding the collection of health data outside the traditional venues for health care.
The Department of Health and Human Services Office for Civil Rights is taking an aggressive stand on HIPAA enforcement and targeting violations related to security risk assessments and business associate agreements. Three resolution agreements posted in the last month make clear that the agency expects entities subject to HIPAA to take appropriate steps to secure their data, regardless of the size or type of the entity.
The Department of Health and Human Services released guidance on July 11, 2016, intended to help the healthcare industry prepare for and respond to ransomware attacks. Specifically, this guidance clarifies: (1) that a ransomware attack is considered a “security incident” under HIPAA, and (2) that a ransomware attack will typically be considered a “breach” by HHS unless entities are able to demonstrate that there is a “low probability of compromise.” The guidance also clarifies that covered entities must implement the same risk assessment processes as they would with other types of cyber threats, including malware. At a time when ransomware attacks are on the rise, this guidance heightens the potential regulatory enforcement consequences of these events.
The FTC released this week a web-based tool to assist mobile app developers in determining which federal privacy laws apply to their mobile health applications. The tool asks developers a series of ten targeted questions that help a user determine whether HIPAA, FTC, and/or FDA rules and regulations might apply.
Hogan Lovells hosted the second annual Health Privacy Law Forum for health privacy professionals yesterday. Participants spoke with Deven McGraw, Deputy Director of Health Information Privacy at the U.S. Department of Health and Human Services Office for Civil Rights , and former Federal Trade Commissioner Julie Brill, now a partner at Hogan Lovells and co-chair of its Privacy and Cybersecurity practice.
The revamped audit protocol for the upcoming HIPAA Phase 2 audits has been released by the US Department of Health and Human Services Office for Civil Rights. The audit protocol, which is posted on the HHS website, includes new requirements added by the 2013 Omnibus Final Rule for HIPAA covered entities and business associates. The Phase 2 audits will be more focused, and the stakes will be higher: the agency has indicated that audits may, in certain circumstances, lead to full compliance reviews—with the potential for fines or settlement agreements related to alleged HIPAA noncompliance. In addition, business associates will be subject to HIPAA audits for the first time.
Last week, the Department of Health and Human Services Office for Civil Rights launched the long-awaited Phase 2 HIPAA Audit Program. Earlier this month, the agency posted two resolution agreements that continue the trend toward big dollar settlement amounts and a focus on security risk assessments and business associate agreements. With Phase 2 HIPAA Audits underway and more full-scale compliance reviews triggered by data breach reports, it is more important than ever to appropriately protect health information.
Following the launch of its mHealth Developer Portal last October, the HHS Office for Civil Rights has released guidance clarifying how HIPAA applies to mobile health apps. Ensuring that developers understand their legal obligations is critical to protecting consumer privacy and security, especially now that there are more than 165,000 health apps available in the iTunes and Android app stores. A more clear understanding of how the rules apply can also help bring down barriers to innovation.
The White House released the Precision Medicine Initiative Privacy and Trust Principles, aimed at building patient trust and protecting patient privacy for precision medicine-related activities last month, as the National Institutes of Health announced the availability of $72 million in PMI-related funding opportunities for fiscal year 2016. A Security Policy Framework that will help ensure that security is built into the foundation of the PMI is in development.
The HHS Office for Civil Rights has launched an online portal designed to solicit questions from mHealth developers regarding compliance with HIPAA privacy and security requirements. The portal is designed to demystify HIPAA for app developers while providing guidance to regulators about which aspects of HIPAA may require clarification.
The HHS Office for Civil Rights needs to improve and expand its health privacy and data breach enforcement efforts. This was the message delivered by the September 29 release of twin reports by the U.S. Department of Health and Human Services Office of Inspector General that assessed OCR’s enforcement of federal health privacy laws. The studies were commissioned out of concern that the failure to adequately safeguard health information can expose large numbers of patients “to privacy invasion, fraud, identity theft, and/or other harm.” The enforcement of the HIPAA privacy laws in the U.S. are viewed as critical to ensuring that vulnerabilities that can lead to data breaches and potential harm to patients are addressed.
Government officials and experts from the private sector discussed enabling precision medicine and efforts to bolster patients’ rights to access medical records, and also emphasized the importance of controlling access to protected health information at the eighth annual “Safeguarding Health Information: Building Assurance Through HIPAA Security” conference held from September 2–3, 2015, and co-hosted by the National Institute of Standards and Technology (NIST) and the Department of Health and Human Services, Office for Civil Rights. Comprehensive risk analysis and risk management practices remained a point of emphasis throughout the conference. This blog post addresses the following additional themes that emerged during the conference.
On December 2, the Department of Health and Human Services, Office for Civil Rights announced a $150,000 settlement with Anchorage Community Mental Health Services, Inc. for alleged violations of the HIPAA Security Rule. The announcement followed an OCR investigation into a breach of unsecured electronic protected health information affecting 2,743 individuals. OCR highlighted three Security Rule violations in its resolution agreement: (1) failure to conduct an accurate and thorough risk analysis; (2) failure to implement security policies and procedures; and (3) failure to have reasonable firewalls in place, as well as supported and patched IT resources. In a press release regarding the settlement, OCR Director Jocelyn Samuels noted that “successful HIPAA compliance . . . . includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”
Government officials emphasized the importance of risk analysis and risk management in safeguarding PHI at the Seventh Annual “Safeguarding Health Information: Building Assurance Through HIPAA Security” conference held from September 23–24, 2014, and co-hosted by the National Institute of Standards and Technology and the Department of Health and Human Services, Office for Civil Rights. The conference’s themes—which include risk analysis and risk management, information sharing, and upcoming OCR enforcement efforts—highlighted how HIPAA regulated entities should approach cybersecurity considerations and compliance with the HIPAA Security Rule.
The 2009 HITECH Act mandated that the U.S. Department of Health and Human Services Office for Civil Rights conduct periodic audits of covered entities and business associates for compliance with HIPAA privacy and security requirements. In 2012, OCR conducted a pilot audit program involving 115 covered entities. In February 2014, the agency issued a notice in the Federal Register announcing its plan to survey up to 1,200 covered entities and business associates to select organizations for the next round of HIPAA audits.
In a recently-announced settlement between the Department of Health and Human Services Office for Civil Rights and a New York health plan, the health plan agreed to pay $1.2 million for the breach of electronic patient records stored in the internal memory of digital photocopiers leased and improperly disposed by the plan.
On November 26, the U.S. Department of Health and Human Services’ Office for Civil Rights released guidance on methods for de-identification of protected health information in keeping with the HIPAA Privacy Rule (as required under the HITECH Act). The guidance answers questions related to each of the permissible de-identification methods – the expert determination […]
Following an extensive investigation by the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR), the Alaska Department of Health and Social Services (DHSS), Alaska’s state Medicaid agency, agreed to pay $1.7 million in fines and to comply with a corrective action plan (CAP) to address gaps in its compliance with the HIPAA Privacy and Security Rules.
The U.S. Department Health and Human Services Office of the Inspector General issued two reports yesterday criticizing the Centers for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health IT (“ONC”) for doing too little to protect the security of patient health information. The first report, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services HIPAA Oversight, found that CMS oversight and enforcement “were not sufficient to ensure that covered entities, such as hospitals, effectively implemented the Security Rule.”