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 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.
The Administration is preparing to release a Request for Information (“RFI”) on potential modifications to Health Insurance Portability and Accountability Act (HIPAA) rules. The draft RFI was recently submitted by the Department of Health and Human Services (“HHS”) to the White House’s Office of Management and Budget (“OMB”) for pre-release review.