Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data

Regulatory NewsRegulatory News | 22 August 2016 |  By 

Several groups representing the medical device industry and patients are calling for more clarity from the US Food and Drug Administration (FDA) on its recent draft guidance on sharing patient-specific device data with patients.

In June, FDA released its draft guidance, Dissemination of Patient-Specific Information From Devices by Device Manufacturers, to clarify that device makers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device used by patients.

Industry Comments

It its comments posted last week, the Advanced Medical Technology Association (AdvaMed) says that FDA should emphasize that the recommendations are suggestions, and that the decision to share such data with patients should remain under the device makers' discretion, rather than expectations by the agency.

Additionally, AdvaMed says that adapting data already generated by devices to meet patient needs might not be feasible for device makers.

"Because most patient-specific information is developed for the healthcare provider or manufacturer, reconfiguring it and restating it can be difficult and burdensome. The most desirable way to communicate patient-specific information to a patient is via the patient's healthcare provider. This line of communication should be emphasized and more clearly states as the primary means for providing patient-specific information," AdvaMed writes.

Another group, Regulatory Compliance Associates, a regulatory consulting firm, calls on FDA to clarify a number of aspects of the guidance, including the agency's expectations for cybersecurity, and how it defines concepts such as data usability and interpretability.

Pfizer subsidiary Hospira also raised an issue with data that are not controlled by manufacturers. "Not all manufacturers can access patient-specific data as the source devices may be under custody of the customer," the company writes.

In its comments, Swiss drugmaker Novartis also says it would like more information from FDA on the verification and validation testing that companies should conduct to ensure that the information given to patients is interpretable.

Patient Groups

FDA also received comments from two patient groups, each of which called for additional clarity.

One group, Facing Our Risk of Cancer Empowered (FORCE) raised concerns that certain types of data, such as genetic information from cancer screenings, carry greater risk than others if misinterpreted.

"With the increasing complexity of multigene panel tests for hereditary cancer syndromes, the potential for misinterpretation of genetic test results is very real. Misunderstanding these results can have serious consequences, as possible life-altering health care and surgical decisions are being made. Most patients—and many health care providers—lack the training or expertise to interpret and understand genetic test results," FORCE writes.

Instead, FORCE suggests FDA consider developing separate guidance for sharing data from devices that could pose a higher risk to patients.

Another group, the Patient, Consumer, and Public Health Coalition says it wants FDA to clarify the section of the guidance on the Health Insurance Portability and Accountability Act (HIPAA), which it says is inconsistent.

"The guidance appears to offer an incorrect interpretation of HIPAA when it states that device manufacturers are prevented under HIPAA from sharing this information with covered entities, such as health plans and health-care providers that electronically transmit health data, without the patient's consent," the group writes, adding that they believe: "HIPAA was never meant to prohibit patient data collected by devices from being shared with the patient's own physicians."

Public Docket


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