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Compliance In Focus
Posted by Sandra Maddock on Mon, Jan 7, 2013

Should Patients Have Access to Data From Their Device?

This question was recently raised by an article published in the Wall Street Journal and a blogShould Patients Have Access to Data published on ieee spectrum. Currently patients cannot have access to the information without going through their healthcare provider. Should industry support patient access to all information pertaining to their medical device?

Currently medical device manufactures generally do not allow patients to have unrestricted access to the medical device data because:

  • The format is not presented in a useful format for the public/patients
  • Allowing patients this type of access would require further FDA approval
  • Increase costs to the manufacturer
  • Lack of demand for public access to this information

FDA currently “requires that the information be only sent to the patients’ hospitals or doctors, who are in fact the device manufacturers’ end-item customers. If a patient want’s to get access to the raw device data, they are told that they have to get it from their healthcare provider.”

Interestingly enough, physicians are not in overwhelming support of patients having access to their device’s information, especially if the data is in raw form. In fact, the article points to the fact that if a patient misreads or misunderstands the signals it could “cause anxiety or even harm.”

The 1996 Health Insurance Portability and Accountability Act (HIPAA) is something that cannot be ignored either. Currently “raw data from an implanted device is not considered to be medical record information under HIPAA which gives a patient the right to access their medical information held by their healthcare provider.” If this were to be considered a medical record, how might the manufactures and Sponsors be effected in clinical research?

How do you feel about this topic? Do you believe that patients have a right to the data their device collects? Or, should patients continue the process of getting the information through a healthcare professional?

Share your thoughts below.

Photo Credit: wawoodworth

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Topics: Patients, Access to Data, FDA, HIPAA


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