HHS finalizes patient health data, interoperability rules

March 9, 2020

The rules require public and private entities to share health information between patients and other parties.

HHS has finalized a pair of rules aimed at giving patients more access to their health information and increasing interoperability, according to a news release from the department.

The pair of rules implement interoperability and patient access provisions of the 21st Century Cures Act as well as supporting President Donald J. Trump’s MyHealthData initiative, which seeks to give patients more access to their health data so they can make informed decisions about their care. These rules require both public and private entities to share health information between patients and other parties, while still keeping the information private and secure, the release says.

“From the start of our efforts to put patients and value at the center of our healthcare system, we’ve been clear: Patients should have control of their records, period. Now that’s becoming a reality,” HHS Secretary Alex M. Azar says in the release. “These rules are the start of a new chapter in how patients experience American healthcare, opening up countless new opportunities for them to improve their own health, find the providers that meet their needs, and drive quality through greater coordination.”

The rules were issued and will be implemented by HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS).

The ONC rule seeks to establish new regulations to prevent health information blocking, or anti-competitive behaviors, by healthcare providers, developers of health information technology, health information exchanges, and health information networks, the release says.

The CMS rule builds on the ONC rule and requires Medicare Advantage, Medicaid, CHIP, and federal exchange health plans to share claims data electronically with patients starting in January 2021, the release says.

This information will be required to be made available to patients “in a safe, secure, understandable, user-friendly electronic format through the Patient Access API,” the release says.

The CMS rule also establishes a new Condition of Participation which requires all Medicare and Medicaid hospitals to send electronic notifications to other healthcare providers when a patient is admitted, transferred, or discharged, the release says.

It is believed the finalization of these two rules were meant to be key parts of Trump’s scheduled address to the HIMSS20 conference March 9 in Orlando, Florida. The speech was called off after the conference, which usually draws tens of thousands of healthcare professionals from around the globe, was canceled due to concerns about the COVID-19 coronavirus.

The industry responds

The American Medical Association (AMA) put out a statement saying the organization was going to review the rules, and would be focusing on these specific areas:

  • Privacy controls that require apps to be transparent about what data is being collected and how the app developers intend to use it, and security safeguards for patients using apps to access health information 

  • Rules that prohibit vendors from charging excessive fees, including “gag clauses” that prevent physicians from publicizing problems with their EHRs 

  • A usage-based fee structure to limit EHR vendor fees and prevent physicians from incurring costs for exchanging health data that complies with federal requirements 

  • Programming tools to improve physician and patient access to health information 

  • More stringent requirements on EHR testing and usability

  • Limiting unnecessary and inappropriate access to EHR data from insurers and other non-clinical entities

  • More clarity and a reduction in the complexity of information blocking exceptions for physicians

  • Less aggressive and separate EHR implementation timelines for vendors and physicians

“The AMA has been advocating on behalf of physicians and patients for over 10 years to ensure EHR usability, interoperability, and patient data and safety are top concerns when government agencies develop new policies,” said AMA President Patrice A. Harris, MD. “We applied this knowledge and momentum as we worked with CMS and ONC in anticipation of today’s release of the final rule. As the AMA reviews the new rules, we will pay special attention to policies aimed at creating efficiencies in data exchange, reduction in physician burden, and patient control over and access to their data.”

The Medical Group Management Association (MGMA) also released a statement on the rules. Anders Gilnber, the group's senior vice president for government affairs, said:

"MGMA supports the Administration’s efforts to facilitate new opportunities for medical practices to share health information with their patients via user-friendly apps. We’re pleased to see CMS’s new hospital admission, discharge, and/or transfer notification requirements, which will better position physician practices to succeed in value-based payment arrangements.

"MGMA is concerned that the ONC rule permits EHR vendors to push API costs onto providers. We will lead industry efforts to protect medical groups from potentially excessive EHR upgrade fees to ensure limited practice resources are not diverted from patient care."