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Sharing Patient-Specific Information from Medical Devices with Patients

This guidance clarifies FDA's position on medical device manufacturers sharing patient-specific information with patients upon request. Patient-specific information includes data recorded, stored, processed, retrieved, or derived from legally marketed medical devices that is unique to an individual patient or their treatment/diagnosis.

  1. Establish a process to handle patient requests for their device-specific information
  2. Develop a format for sharing patient-specific information that is comprehensive and user-friendly
  3. Create standard disclaimers advising patients to consult healthcare providers for interpretation
  4. Review applicable privacy regulations and ensure compliance when sharing information
  5. Document cases where information sharing is not feasible due to technical limitations
  6. Review any supplemental materials provided with patient-specific information to ensure compliance with labeling requirements
  7. Maintain records of patient information requests and responses
  8. Train relevant staff on the information sharing policy and procedures

Key Considerations

Labelling

  • Any supplemental information provided with patient-specific information that constitutes labeling must comply with FD&C Act requirements
  • Patient-specific information itself is generally not considered “labeling” under FD&C Act

Other considerations

  • 45 CFR Part 160: Privacy of Individually Identifiable Health Information
  • 42 U.S.C. § 300gg: Health Insurance Portability and Accountability Act

Original guidance

  • Sharing Patient-Specific Information from Medical Devices with Patients
  • HTML / PDF
  • Issue date: 2017-10-30
  • Last changed date: 2019-02-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: 810078378880acefdb8becce109dd69b
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