On July 26, Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar said that HHS will undertake an effort to reform federal health privacy rules, including those under HIPAA and the rules governing substance abuse treatment records at 42 C.F.R. Part 2 (Part 2). In speaking about efforts by the Trump Administration to improve value-based care efforts that improve efficiency and reward outcomes in clinical treatment, Secretary Azar said that, “in the coming months,” HHS plans to release requests for information on HIPAA and Part 2. Following those requests, HHS will undertake “regulatory action to reform these rules.” Secretary Azar noted that these rules hinder not only value-based care, but also efforts to combat opioid addiction.
The HIPAA rules were last overhauled in 2013 when HHS promulgated the Omnibus Final Rule, following enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009. Notably, the Omnibus Final Rule made the HIPAA rules directly applicable to business associates. However, the Omnibus Final Rule did not address what critics view as barriers to sharing data in the HIPAA rules, which may hinder efforts to encourage providers to adopt electronic health technology more broadly. Recently, CMS has touted efforts to promote patient access to health data among Medicare beneficiaries, though CMS has not said whether these efforts will involve changes to HIPAA rules. It is possible that HHS will use this opportunity to make the HIPAA rules more supportive of efforts by CMS to encourage broader adoption of health care technology.
In any event, companies with interest in health privacy regulations should consider submitting ideas or policy proposals to HHS when the request for information is issued.