HHS Finalizes New Health Data Rules To Improve Data Governance

In an effort to give patients more control over their health data, the U.S. Department of Health and Human Services (HHS) on Monday finalized two new rules designed to grant more interoperability to how patients access their own data.

The rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), were announced last year but it’s believed they could begin affecting healthcare organizations before 2020 is through.

Today, HHS finalized two transformative rules that will give patients unprecedented safe, secure access to their health data. Read more: https://t.co/c0ogCQCLTy @CMSGov @ONC_HealthIT https://t.co/HWE8ikMFvB pic.twitter.com/pz2cYKw2HI

— HHS.gov (@HHSGov) March 9, 2020

One rule, the Interoperability and Patient Access final rule (CMS-9115-F), would compel Medicare Advantage, Medicaid, CHIP, and patients whose health plans go through federal Exchanges to share claims data electronically with patients. As expected, CMS and ONC are planning on using HL7 (Health Level 7) as the means to support data exchange via APIs.

"Lack of seamless data exchange in healthcare has historically detracted from patient care, leading to poor health outcomes, and higher costs," the Centers for Medicare and Medicaid Services said in guidance on Monday, "The CMS Interoperability and Patient Access final rule establishes policies that break down barriers in the nation’s health system to enable better patient access to their health information, improve interoperability and unleash innovation, while reducing burden on payers and providers. "

The other rule, the latest version of the 21st Century Cures Act, focuses on interoperability and patient information blocking. The act seeks to end anti-competitive behaviors by healthcare providers, developers of certified health IT, health information exchanges, and health information networks. If the actions satisfy an exception, the actions won't be treated as information blocking and the actor wouldn't be subject to civil penalties.

“Delivering interoperability actually gives patients the ability to manage their healthcare the same way they manage their finances, travel and every other component of their lives,” Don Rucker, MD, National Coordinator for Health Information Technology. “This requires using modern computing standards and APIs that give patients access to their health information and give them the ability to use the tools they want to shop for and coordinate their own care on their smartphones.”

Stakeholders claim the increased visibility afforded by the finalized rules should enhance patient privacy.

"We are holding payers to a higher standard while protecting patient privacy through secure access to their health information,” CMS Administrator Seema Verma said, “Patients can expect improved quality and better outcomes at a lower cost.”

Verma added that in six months, Medicare- and Medicaid-participating hospitals will have conform to the CMS rule by sending admission, discharge, and transfer notifications so patients receive timelier follow ups.

Both rules, in their entirety, are lengthy. To learn more about the Interoperability and Patient Access final rule, interested parties can read the 474 page document here.

The 1244-page 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program document can be found here.