In an effort to reduce barriers to coordination of care, the U.S. Department of Health and Human Services (“HHS”) is considering changes to Federal restrictions on the sharing of substance use disorder (“SUD”) records. The proposed changes would modify 42 C.F.R. Part 2 (“Part 2”) regulations that place restrictive conditions on the disclosure of SUD patient records—limitations that go above and beyond Health Insurance Portability and Accountability Act (“HIPAA”) restrictions.
The barriers imposed by these rules—which have been in place since the 1970s—have become the focus of particular attention in light of the opioid crisis, as members of Congress and other stakeholders have raised concerns about how the Part 2 statute and implementing regulations may inhibit efforts to respond and coordinate care. Members of Congress have called for reform, but have been unsuccessful at seeking legislative fixes thus far.
New Annual HIPAA Penalty Tiers
Six months after imposing the largest ever HIPAA fine ($16 million) following a HIPAA data breach, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) has announced that it is exercising its enforcement discretion to lower maximum annual HIPAA penalties.
On January 28, 2019, the Healthcare and Public Health Sector Coordinating Council released the “Medical Device and Health IT Joint Security Plan” (“JSP” or “Plan”)—cybersecurity recommendations for medical device manufacturers, healthcare information technology vendors, and healthcare providers. U.S. Government entities, including the FDA, participated in the development of the Plan. The JSP comes close on the heels of the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” a similar effort by a public-private partnership to provide cybersecurity guidance to healthcare industry stakeholders. (more…)
On 23 January 2019, the European Data Protection Board (EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (CTR) and the EU General Data Protection Regulation (GDPR). The Opinion addresses the appropriate legal basis for the processing of personal data in the context of clinical trials (primary use), and the secondary use of clinical trial data. (more…)
On December 3, 2018, twelve attorneys general (“AGs”) jointly filed a data breach lawsuit against Medical Informatics Engineering and its subsidiary, NoMoreClipboard LLC (collectively “the Company”), an electronic health records company, in federal district court in Indiana. See Indiana v. Med. Informatics Eng’g, Inc., No. 3:18-cv-00969 (N.D. Ind. filed Dec. 3, 2018). The suit—led by Indiana Attorney General Curtis Hill—is joined by AGs from Arizona, Arkansas, Florida, Iowa, Kansas, Kentucky, Louisiana, Minnesota, Nebraska, North Carolina and Wisconsin. While state AGs have previously exercised their civil enforcement authorities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this is the first multi-state data breach lawsuit alleging HIPAA violations in federal court and may signal increased interest on the part of state officials in exercising their data protection authorities to address cybersecurity incidents.
On January 25, 2019, the Illinois Supreme Court unanimously held that a plaintiff does not need to allege any actual injury or damages to successfully state a claim under the Illinois Biometric Information Privacy Act (BIPA). Rosenbach v. Six Flags Entertainment Corp., 2019 IL 123186 (Jan. 25, 2019) (a copy of the opinion is available here). A violation of the statute by itself is sufficient to state a claim, even if no breach or misuse of the biometric information or identifier has occurred. Because BIPA includes stiff liquidated damages for violations, the court’s ruling is likely to lead to renewed interest by the plaintiffs’ bar in class action suits alleging BIPA violations. (more…)
On December 28, 2018, the U.S. Department of Health and Human Services (HHS) released a four-volume cybersecurity guidance document for healthcare organizations. The publication, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP), is the result of a government and industry collaboration mandated by the Cybersecurity Act of 2015. The HICP is not limited to individually identifiable health information but instead covers organizations’ enterprise-level information security more generally. HHS describes the publication as “practical, understandable, implementable, industry-led, and consensus-based voluntary cybersecurity guidelines to cost-effectively reduce cybersecurity risks for healthcare organizations of varying sizes.” Notwithstanding their voluntary nature, these HHS-backed cybersecurity recommendations are likely to serve as an important reference point for the industry. (more…)
On December 14, 2018, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published in the Federal Register a request for information (RFI) titled “Modifying HIPAA Rules to Improve Coordinated Care.” The RFI seeks public input on a broad range of potential reforms to Health Insurance Portability and Accountability Act (HIPAA) regulations with a focus on enhancing care coordination. Though only a preliminary step on the path to potential regulatory reform, the RFI’s scope is significant, as is the opportunity it affords stakeholders interested in sharing early input as HHS considers reforms to key health information privacy requirements. (more…)
The National Association of Insurance Commissioners (NAIC) held its Fall 2018 National Meeting (Fall Meeting) in San Francisco, California, from November 15 to 18, 2018. This post summarizes the highlights from this meeting. (more…)
The U.S. Department of Commerce, Bureau of Industry and Security (BIS) has published an advance notice of proposed rulemaking (ANPRM) initiating a 30-day public comment process regarding export controls for certain emerging technologies. The notice launches the implementation of a key provision of the Export Control Reform Act of 2018 (ECRA), part of the National Defense Authorization Act for fiscal year 2019 (NDAA). In the ECRA, Congress authorized BIS to establish controls on the export, reexport and transfer (in country) of “emerging and foundational technologies.” The ANPRM, including a list of the 14 proposed representative technology categories and subcategories subject to review, can be found here. Our prior updates on the NDAA and ECRA can be found here.