HHS Finalizes Data Sharing Rules

On March 09, 2020, two U.S. Department of Health and Human Services (HHS) agencies released a pair of final rules regarding patient access to data, data blocking, and interoperability. Initially proposed last year, the rules significantly update how providers, insurers and patients exchange health data and are intended to support seamless and secure access, exchange and use of electronic health information (EHI). In general, the rules require health care providers and insurers to adopt standardized application programming interfaces (APIs), which connect information technology (IT) systems such as electronic health records with third-party apps, and allow individuals to access their EHI through smartphone apps.

The first rule [PDF], Interoperability and Patient Access, from HHS’s Centers for Medicare & Medicaid Services (CMS) requires issuers of Medicare Advantage, Medicaid, CHIP and Exchange individual health plans to make patient EHI downloadable using a common data sharing standard. It also requires hospitals to send electronic admissions, discharge and transfer information to patients’ primary care providers.

The second rule, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, from the Office of the National Coordinator of Health Information and Technology (ONC) requires health IT vendors to make patient data downloadable using the same common data sharing standard. Additionally, the ONC rule prohibits “information blocking,” which includes any practice by a provider, health IT developer, health information exchange, or health information network that interferes with, prevents, or materially discourages access, exchange, or use of EHI with certain exceptions. The rule further outlines situations in which blocking data transfer would be allowed, including instances when releasing certain information could harm the patient.

The effective dates of these rules are 60 days after the date they are formally published in the Federal Register; however, some requirements have later effective dates ranging from Jan. 1, 2021 to Jan. 1, 2022.

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