The trend toward self-management by patients of their own health care has now pushed the FDA to offer guidance to makers of medical devices that collect, store and disseminate data – especially relevant given the rapid move toward wearable or implantable medical devices.
“FDA believes that providing patients with access to accurate, usable information about their health care when they request it (including the medical products they use and patient-specific information these products generate) will empower patients to be more engaged with their health care providers in making sound medical decisions,” the agency said in its draft guidance.
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The position taken by the agency is “very patient friendly,” Patricia Wagner, a Washington-based attorney with Epstein Becker & Green P.C., told Bloomberg BNA
But it does present some tricky challenges for manufacturers, she stressed. These include the need to determine when it is okay to provide patients with data, made more complex because there are numerous variations in interpretations of the key health privacy law, the Health Insurance Portability and Accountability Act (HIPAA).
Despite privacy concerns, this latest agency guidance fits the trend toward increased patient involvement. “Today, many medical devices have the ability to store data and transfer it to medical records, so this seems like a natural progression in providing patient access,” Chris Lavanchy, with the patient safety organization ECRI Institute told Bloomberg BNA
Because the data is readily available, patients, “especially younger ones who have grown up with access to their medical records, will welcome having access to device data so that they can play a bigger role in making decisions about their health care,” he advised.
But a key issue device makers need to consider: what specific data is covered by this sharing guidance?
The FDA stated that it is referring to “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.”
Such shareable information would include data on such things as usage, alarms, or physiological outputs. The latter would include, for example, logs entered by patients or caregivers, pulse oximetry data, heart electrical activity, and rhythms, such as those monitored by a pacemaker.