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HHS Releases Final 2 Rules About Interoperability of Healthcare Data


The rules seek to end information blocking and give patients more control and choice over their data.

The Trump administration Monday released 2 final rules relating to the interoperability of healthcare data.

The rules seek to end information blocking and give patients more control and choice over their data.

The 2 rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and CMS, implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act as well as the MyHealthEData initiative, which is aimed at giving patients their own medical information.

“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,” said HHS Secretary Alex M. Azar in a statement.

“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. 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,” said Don Rucker, MD, national coordinator for health information technology (IT), in a statement. “A core part of the rule is patients’ control of their electronic health information which will drive a growing patient-facing healthcare IT economy, and allow apps to provide patient-specific price and product transparency.”

Not everyone is on board with the new rules. In January, Last month, Epic, the nation’s largest provider of electronic health record (EHR) software, asked that the rules be delayed, saying that patient privacy is at stake.

In a statement Monday, the American Hospital Association said the “final rule fails to protect consumers’ most sensitive information about their personal health. The rule lacks the necessary guardrails to protect consumers from actors such as third-party apps that are not required to meet the same stringent privacy and security requirements as hospitals. This could lead to third party apps using personal health information in ways in which patients are unaware.”

The ONC said the final rule identifies and finalizes which activities do not constitute information blocking while setting rules to prevent anticompetitive behaviors by healthcare providers, developers of certified health IT, health information exchanges, and health information networks as required by the Cures Act.

Currently, many EHR contracts contain provisions that either prevent or are perceived to prevent users from sharing information related to the EHRs in use, such as screen shots or video, HHS said.

The ONC final rule also requires EHRs to provide the clinical data necessary, including core data classes and elements, to promote new business models of care.

The CMS Interoperability and Patient Access final rule requires health plans in Medicare Advantage, Medicaid, and plans through the federal Exchanges to share claims data electronically with patients.

The rule sets standards-based application programming interface (API) requirements to support a patient’s access and control of their electronic health information delivered through a smartphone app.

Under the CMS rule, all Medicare and Medicaid participating hospitals are required to send electronic notifications to another healthcare facility or community provider or practitioner when a patient is admitted, discharged, or transferred. CMS believes the notifications will allow for better care coordination and improve patient outcomes.

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