Regulatory Trend. Data Security in Medical Devices. Policymakers Requiring Disclosures. Coming to an health agency near you.

Who is making a request that medical device makers disclose component parts? House Committee on Energy and Commerce

On what agency are these policymakers making a request? Department of Health and Human Services

What is Department of Health and Human Services​ being asked to do?

  • Require medical device manfuacturers to dislcose:
    • bill of materials (BOM) for each piece of medical technology
    • describe the device’s components
    • describe software utilized
    • disclose any known risks associated with those parts
  • To promote cybersecurity through transparency

SC Media | House committee asks HHS to boost cybersecurity by requiring component list for medical devices