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.
Recommended Actions
- Establish a process to handle patient requests for their device-specific information
- Develop a format for sharing patient-specific information that is comprehensive and user-friendly
- Create standard disclaimers advising patients to consult healthcare providers for interpretation
- Review applicable privacy regulations and ensure compliance when sharing information
- Document cases where information sharing is not feasible due to technical limitations
- Review any supplemental materials provided with patient-specific information to ensure compliance with labeling requirements
- Maintain records of patient information requests and responses
- 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
- Information shared should be comprehensive and contemporary
- Manufacturers should advise patients to contact healthcare providers for interpretation of the information
- Sharing patient-specific information does not require additional premarket review
- Manufacturers must comply with HIPAA and other applicable privacy regulations
- Information sharing may not be feasible for devices with closed systems or inaccessible formats
- Manufacturers may format the information to improve usability for patients
Relevant Guidances
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Content of Premarket Submissions for Device Software Functions
- Policy for Device Software Functions and Mobile Medical Applications
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
Related references and norms
- 45 CFR Part 160: Privacy of Individually Identifiable Health Information
- 42 U.S.C. § 300gg: Health Insurance Portability and Accountability Act
Original guidance
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