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Regulators Look to Increase Interoperability and Patient Access to Health Data

Federal regulators are flexing their regulatory muscle to accelerate a long-desired but often elusive goal: the interoperability of health information technology (health IT) systems. Interoperability refers to the ability of different health IT systems, including electronic health record (EHR) systems, to meaningfully communicate with one another.  

ONC's Proposal: Interoperability, Information Blocking and More

The Office of the National Coordination for Health Information Technology (ONC) released a proposed rule entitled 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program on February 11th. The proposal would implement certain provisions of the 21st Century Cures Act, including certification obligations for health IT vendors under the ONC Health IT Certification Program and the voluntary certification of health IT for use by pediatric health care providers. According to the ONC:

The proposed rule places a strong focus on a patient's ability to access their health information through a provision requiring that patients can electronically access all of their electronic health information (structured and/or unstructured) at no cost. Finally, to further support access and exchange of electronic health information, the proposed rule implements the information blocking provisions of the Cures Act. The rule proposes seven exceptions to the definition of information blocking.

ONC focuses a good deal of the rule on application programming interfaces (APIs). APIs are built into IT systems to allow other systems to interact with them. For example, when a mobile app like Yelp plots your search results on a Google Map, this is only possible because Google has made available an API that allows the Yelp app to ask the Google Map servers to run your search and send back a map with the results nicely formatted. In the same manner, APIs built into health IT systems would allow other applications to interact with the system, depending on how the API is constructed.     

CMS' Proposal: Interoperability and Patient Access Proposed Rule

CMS released the Interoperability and Patient Access Proposed Rule on February 11th. This proposal aims to increase the level of access that patients have to the information they need to make informed, responsible health care decisions, including data about prices, costs, and outcomes. CMS' role here cannot be overstated: whereas ONC's authority is limited to regulating health IT matters, CMS has much broader authority to regulate interoperability and data access across a wide swath of government programs, including Medicare, Medicaid, CHIP, and qualified health plans. And, as CMS describes in the proposal, they see health plans as playing a crucial role:

All payers, including health plans, should have the ability to exchange data seamlessly with other payers for timely benefits coordination or transitions, and with providers to facilitate more coordinated and efficient care. Health plans are in a unique position to provide enrollees a complete picture of their claims and encounter data, allowing patients to piece together their own information that might otherwise be lost in disparate systems. This information can contribute to better informed decision making, helping to inform the patient’s choice of coverage options and care providers to more effectively manage their own health, care, and costs.

What we see here is the beginning of a one-two punch from health IT regulators on one hand and health care program regulators on the other. We will continue to monitor these develops as they unfold. 

*Olivia Graham contributed to this post.

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Author

Jordan T. Cohen

Associate

Jordan T. Cohen is a Mintz attorney who counsels health care clients on regulations, including the Stark Law, the Anti-Kickback Law, and the Anti-Markup Rule, as well as HIPAA's Privacy Rule and Security Rule. Jordan also has experience in health care transactional matters.