On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices.
The draft guidance defines patient-specific information as “any information unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of a medical device, may be recorded, stored, processed, retrieved, and/or derived from that medical device.” According to the guideline, patient-specific information include recorded patient data, device usage/output statistics (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker), healthcare provider inputs, incidence of alarms, and/or records of device malfunctions or failures.
According to the draft guideline, manufacturers may share patient-specific information with a patient at the patient’s request without obtaining additional premarket review. The Health Insurance Portability and Accountability Act (HIPAA) and the associated HIPAA Privacy Rule intend to prevent manufacturers from sharing individually identifiable health information with covered entities (e.g., health plans, healthcare clearinghouses, and healthcare providers that electronically transmit health information) without the patient’s consent. However, the draft guideline opines that HIPAA and the HIPAA Privacy Rule are not intended to prevent a medical device manufacturer from sharing patient-specific information with the affected patient.
In the draft guideline, FDA recommends that device manufacturers should take certain considerations into account when sharing patient-specific information. These considerations relate to the content of information provided, the context in which patient information from medical devices should be understood, and the need for access to additional, follow-up information from the manufacturer or a healthcare provider.
1. Content
FDA recommends that a manufacturer take appropriate measures 1) to ensure that the information provided is interpretable and useful to the patient and 2) to prevent the disclosure of confusing or unclear information that could be misinterpreted. For example, the manufacturer may provide supplementary instructions, materials, or references to aid patient understanding. Patient-specific information provided to patients should be comprehensive and contemporary.
2. Context
When providing patient-specific information to the affected patient, it may be appropriate for the device manufacturer to include relevant context in order to avoid circumstances where this information may be misinterpreted, thus leading to incorrect or invalid conclusions. Informing patients about how parameters were measured and recorded by the medical device is a good example of providing relevant context.
3. Access to follow-up information
Manufacturers should consider what, if any, information they should include about whom to contact for follow-up information. The FDA recommends, at a minimum, that such manufacturers advise patients to contact their healthcare providers if the patients have any questions about their patient-specific information. Moreover, FDA suggests that manufacturers provide their contact information to answer questions from patients about the device at issue.
Comments and suggestions for the draft guideline are open for 60 days from its publication.
