Industry, Patient Groups Seek Clarity From FDA On Sharing Patient-Specific Device Data

By Jof Enriquez,
Follow me on Twitter @jofenriq

Patient organizations and industry groups want the U.S. Food and Drug Administration (FDA) to clarify salient points in its draft guidance on how manufacturers should share patient-specific data with patients.

FDA in June released the draft guidance, which contains recommendations on how to share patient-specific information (recorded, stored, processed, retrieved, and/or derived from a medical device, consistent with the intended use of that medical device) with patients, either on the manufacturer’s own initiative or at the patient’s request.

In comments to FDA, the Advanced Medical Technology Association (AdvaMed) writes that the regulator should "more clearly state that the information on content and context are suggestions, not requirements and should be implemented when feasible." AdvaMed suggests that FDA add language that manufacturers are "not obligated" to share patient-specific information.

AdvaMed writes that reconfiguring and restating patient-specific information originally developed for the healthcare provider or manufacturer can be "difficult and burdensome," and asserts that this type of information should ideally come from the patient's healthcare provider. Therefore, the group says that FDA should clearly state that this line of communication between the patient and the clinician is "the primary means for providing patient-specific information."

FDA's draft guidance states that patient-specific data should be provided in "relevant context" and to avoid " disclosure of confusing or unclear information that could be misinterpreted” by patients.

Advocacy group Facing Our Risk of Cancer Empowered (FORCE) expressed concern about the potential for misinterpretation of genetic test results, and suggests FDA consider developing separate guidance for sharing data from devices that could pose a higher risk to patients, according to RAPS.

Regulatory Compliance Associates (RCA), a medtech consulting firm, says the draft guidance fails to define "relevant context" considering that most patients are laypeople with very limited understanding of the technology of the medical device and how to correlate clinical data.

"By providing too much information, it may actually cause the patient to be more confused and unable to make health decisions for themselves," writes RCA. 

Another group, the Patient, Consumer, and Public Health Coalition, expressed a similar view, writing, "If the information from the device is summarized, key data could be omitted. Alternatively, if all data is released (e.g. via data dump), the information could be overwhelming and useless to the patient."

That presumes that all manufacturers have access to patient-specific data from medical devices that are already in the field, according to Hospira, but in reality, not all manufacturers have access "as the source devices may be under the custody of the customer."

Commenters to the draft guidance also took issue with how FDA states that protections under the Health Insurance Portability and Accountability Act (HIPAA) are "intended to prevent manufacturers from sharing this information with covered entities (e.g., health plans, healthcare providers that electronically transmit health information)."

AdvaMed suggests FDA delete the incorrect text, stating that HIPAA's purpose was "to improve treatment by easing provider-to-provider communications" and with certain limitations, permits that "information from a medical device would need to be disseminated to a physician in order for the physician to make treatment/diagnosis decisions."

The Patient, Consumer, and Public Health Coalition writes, "We agree that HIPAA was never meant to prohibit patient data collected by devices from being shared with the patients’ own physicians. Clarification of these issues is needed."