- FDA has issued final guidance to authorized medical device manufacturers, clarifying that it is acceptable for those manufacturers to open patient access to health data for those patients who request access.
The guidance states that medical device manufacturers are not prohibited from sharing this information with patients and providers upon request. The guidance does not amend any current law, including HIPAA, nor does it override any existing FDA governance. The guide simply serves as a clarification for medical device manufacturers.
Medical devices can store patient data related to diagnosis and treatment, and this data can play a huge role in improving patient engagement with care, said FDA Commissioner Scott Gottlieb, MD.
"Providing patients with accurate and complete information about their diagnosis and treatment, including the data collected from medical devices like blood pressure or heart rhythm monitors, allows patients to be better informed about their health and more active participants in their health care decisions,” Gottlieb explained in a statement.
“We want to eliminate any policy obstacles that might prevent manufacturers from sharing with patients their own personal health information captured by their legally-marketed medical devices,” Gottlieb added.
The guidance addresses “patient-specific information,” or what FDA describes as “information unique to an individual patient or unique to that patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device.”
In most cases, patients who want access to their health information will go to their medical providers to obtain that data. However, patients also have the right to contact medical device manufacturers, FDA stated. In these cases, manufactures need to oblige patient requests.
Manufacturers must offer complete and updated information to patients. For example, if a medical device stores blood test information, those results must include all test results up until the most recent test. Manufacturers are also obligated to offer these results in a form accessible to patients.
In cases where manufacturers would need to reconfigure devices to obtain patient data, FDA said manufacturers do not need to fulfill patient requests.
FDA also suggested medical device manufacturers collaborate with healthcare providers.
“FDA recognizes the important role healthcare providers play in providing interpretation of and context to patient-specific information,” the agency wrote. “FDA recommends that manufacturers advise patients to contact their healthcare providers should they have any questions about their patient-specific information.”
This guidance is a key step in facilitating better patient engagement in healthcare, the agency wrote. The industry landscape is changing in such a way that patient access to health data is critical for an activated patient.
“Increasingly, patients seek to play an active role in their own healthcare,” FDA explained. “FDA believes that sharing “patient-specific information” with patients upon their request may assist them in being more engaged with their healthcare providers in making sound medical decisions.”
The guidance is a part of FDA’s larger attempts at becoming more patient-centric, according to Gottlieb.
“This guidance is one of several steps the FDA is taking across the agency to encourage transparency through greater access to health information – such as recent efforts to improve access to reports of adverse drug reactions and steps we will take soon to increase the access patients and providers have to the bottom line medical information that we evaluate as part of our drug review program,” Gottlieb concluded.
“We’re committed to continuing to identify new ways the agency can help foster transparency and patient access to accurate clinical information as a way to improve patient outcomes and health care delivery."
Earlier this year, FDA also started holding meetings specifically about patient engagement with medical device management. In October, the agency held its first patient engagement advisory committee meeting, where committee members discussed methods by which FDA can help patients participate in medical device development and testing.
The agency has also introduced provisions to streamline some regulatory actions. Often, medical devices undergo updates that must be authorized by FDA. These updates are implemented to improve patient care, but the authorization process can often stall patient access.
Streamlining those authorizations can help patients access updated devices more openly. While those provisions make no changes in FDA regulations and will not relax the standards at which FDA holds devices, it will make it easier for patients to access these tools.
As the healthcare industry continues to both embrace a more patient-centric strategy as well as use more medical devices, it will be important for patients to have access to the best tools possible. Streamlining tool regulation and allowing patient access to health data will support both of those goals, FDA says.