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Volume: 4 Issue: 11
(November 2017)

fd guidance offers clarity manufacturer data sharing u.s food drug administration (‘fd published 30 october 2017 final version guidance


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FDA Guidance offers clarity on manufacturer data sharing

The U.S. Food and Drug Administration (‘FDA’) published on 30 October 2017 the final version of its guidance, ‘Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request’ (‘Guidance’), clarifying that the FDA’s requirements do not prevent manufacturers of medical devices which store inputs from healthcare providers regarding a patient’s status and ongoing treatment, or that record information about usage, alarms or outputs, from sharing patient-specific data recorded by the device with the patient diagnosed by or being treated with that device. “This is a circumstance in which the FDA is clarifying a question on which it has not previously provided guidance. The purpose of the Guidance is to facilitate sharing of data with patients when that is requested by the patient, but only if the manufacturer already has access to the information and does not need to alter the device in order to obtain the requested information,” explains Yarmela Pavlovic, Partner at Hogan Lovells.

The FDA launched a consultation on a draft version of the Guidance in June 2016, following earlier reports about patients having difficulty when trying to get hold of data from medical devices, with some manufacturers concerned that to provide such information would need approval from the FDA. “The sharing of this data can potentially extend relationships with patients because manufacturers can provide patients with pertinent information about their health along with the devices,” comment Cori Annapolen Goldberg, Partner, Krishna Kavi, Associate, and Rob Kantrowitz, Law Clerk, of Norton Rose Fulbright US LLP.

The manufacturer is under no obligation to provide data and whether it does so will be an internal decision. “In some cases, patient specific information may not be useful without having a medical professional interpret the information,” said David M. Hoffmeister, Partner at Wilson Sonsini Goodrich & Rosati. “Furthermore, patient data collected by a medical device does not cover an analytical report that may be prepared by the manufacturer and provided to the healthcare professional for interpretation, e.g., a report analysing aggregate data from a heart monitor.” “Many manufacturers may not have access to patient data,” adds Pavlovic. “For example, many mobile applications with data stored on the cloud are designed such that data are encrypted except when viewed by authorised users. If the manufacturer does not already have a right to access the data, the Guidance is clear that they should not make changes only to provide the requested data. In addition, there are instances in which the company may have access to data that feeds into a final output for the user. The FDA makes clear in the Guidance that it is not intended to permit disclosure of these data unless they are part of the intended output of the device.”

According to FDA Commissioner Scott Gottlieb, M.D., the Guidance is a step towards “[encouraging] transparency through greater access to health information.” However, “Manufacturers should be wary not to cross the lines of diagnosing or evaluating the patient-specific information when they provide it to the patients, as that role should be left to providers,” note Goldberg, Kavi, and Kantrowitz. “It is also important to note that the FDA does not intend this Guidance to change privacy protections in place through HIPAA and the associated HIPAA Privacy Rule.”

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