Sunday, December 22, 2024

Sunday, December 22, 2024

21st Century Cures Act: Interoperability, information blocking and the ONC Health IT Certification Program


While today's technology offers us a world of information that previous generations never even dreamed of being so accessible, important medical and health records remain time-consuming and difficult to obtain.

The Office of the National Coordinator (ONC) for Health Information Technology is seeking to change that by implementing provisions to the 21st Century Cures Act that would mandate, among other things, standard software protocols allowing computers to share information in such a way that the average user can access that it “without special effort.” The revised act would also prevent the blocking of information by one or more entities.

Currently, some providers offer health care apps that might allow patients to make appointments, read physician instructions and see some test results, but user have to make a formal request to a hospital, specialist or independent lab to access certain data. A comprehensive view of patients' complete medical and health picture is available to providers but not to the patients, depriving them of often critical information and thus potentially impeding their ability to make health decisions for themselves.

“I'm optimistic that we as patients and consumers will finally have deep insight into our own health and new data to prevent sickness,” Dr. Dan Rucker stated on the ONC website.

While privacy is of course a major concern, ONC points out a possible drawback in the fact that while patients would be able to control what data an app could access, they could not necessarily control what happens to that information once it is gathered into an app, and consumers would need to exercise caution.

The U.S. Dept. of Health and Human Services is seeking public comment on the proposed rule through May 3.

The full text of the Act and a vehicle for commenting are available on the Federal Register website.

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FDA Reporter