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.
What You Need to Know? 👇
What is patient-specific information from medical devices according to FDA guidance?
Patient-specific information is data unique to an individual patient or their treatment/diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device. This includes patient data, device usage statistics, healthcare provider inputs, alarms, and device malfunction records.
Can medical device manufacturers share patient data directly with patients upon request?
Yes, manufacturers may share patient-specific information with patients upon their request without additional premarket review. However, this is not required under the Federal Food, Drug, and Cosmetic Act. The FDA generally supports this practice to enhance patient engagement in healthcare decisions.
Does sharing patient-specific information require FDA premarket approval?
No, manufacturers generally may share patient-specific information with patients without undergoing additional premarket review in advance. The FDA considers this practice acceptable as long as it follows the guidance recommendations and applicable regulations for any accompanying labeling materials.
What are the limitations when manufacturers cannot access patient data from devices?
Some devices record information in formats not easily shared or retain data in closed systems inaccessible to manufacturers. In such cases, it may not be feasible to share patient-specific information, as this would require device redesign or accessing unavailable information.
How should manufacturers format patient-specific information when sharing with patients?
Patient-specific information should be comprehensive and contemporary, including all available data up to the most recent measurements. Manufacturers may format the information to facilitate usability and should advise patients to contact their healthcare providers for interpretation and context of the data.
Does this FDA guidance override HIPAA privacy requirements for medical device data?
No, this guidance does not affect federal, state, or local laws like HIPAA and the HIPAA Privacy Rule. These regulations remain applicable to the provision of patient-specific information. The guidance complements existing privacy laws rather than superseding them.
What You Need to Do 👇
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