Health IT

Feds propose streamlined strategy for health IT

health data

The federal government wants to carve out some areas of health IT that don't require oversight by the Food and Drug Administration, while making sure medical devices and other areas that directly affect patient health and safety remain subject to regulation.

A new report from the FDA, the Federal Communications Commission and the Office of the National Coordinator of Health IT (ONC) proposes a "risk based" approach to health IT that gives developers latitude to build computer applications for health records and capturing patient data without the long lead times and trials that accompany FDA approval. Under the proposed system, the FDA would focus on device functionality, including computer-aided detection systems and alarms that alert caregivers to changes in a patient's condition.

The proposed approach is part of an overall strategy to help provide more regulatory clarity to the growing medical IT industry and to encourage firms to focus on standard-setting, interoperability and best practices in the development of health IT to improve data portability and the more efficient delivery of care.

In particular, the report recommends that industry stakeholders establish some method of testing, validating and certifying the interoperability of health care IT systems and devices. Additionally, the government wants to see some performance verification to rate the quality and safety of health IT products. This function could be split among private sector and government bodies, depending on whether an assessment is "critical to assuring the safety and health of consumers," per the report.

Finally, the agencies advocate the creation of a Health IT Safety Center, a new public-private entity that would serve as a clearinghouse for best practices, governance, and information sharing. While the report isn't binding, the agencies are seeking more input from industry on privacy and security issues arising from creating a new quasi-regulatory body.

About the Author

Adam Mazmanian is executive editor of FCW.

Before joining the editing team, Mazmanian was an FCW staff writer covering Congress, government-wide technology policy and the Department of Veterans Affairs. Prior to joining FCW, Mazmanian was technology correspondent for National Journal and served in a variety of editorial roles at B2B news service SmartBrief. Mazmanian has contributed reviews and articles to the Washington Post, the Washington City Paper, Newsday, New York Press, Architect Magazine and other publications.

Click here for previous articles by Mazmanian. Connect with him on Twitter at @thisismaz.


Featured

  • Cybersecurity

    DHS floats 'collective defense' model for cybersecurity

    Homeland Security Secretary Kirstjen Nielsen wants her department to have a more direct role in defending the private sector and critical infrastructure entities from cyberthreats.

  • Defense
    Defense Secretary James Mattis testifies at an April 12 hearing of the House Armed Services Committee.

    Mattis: Cloud deal not tailored for Amazon

    On Capitol Hill, Defense Secretary Jim Mattis sought to quell "rumors" that the Pentagon's planned single-award cloud acquisition was designed with Amazon Web Services in mind.

  • Census
    shutterstock image

    2020 Census to include citizenship question

    The Department of Commerce is breaking with recent practice and restoring a question about respondent citizenship last used in 1950, despite being urged not to by former Census directors and outside experts.

Stay Connected

FCW Update

Sign up for our newsletter.

I agree to this site's Privacy Policy.