On Episode 120 of Health in 2 Point 00, Jess asks me about health data sharing company Particle Health raising $12 million in an A round, AliveCor and OMRON partnering in a remote monitoring play for combined EKG and blood pressure monitoring, and Compass Pathways scoring $80 million in a B round for psilocybin therapy for treatment-resistant depression. Also, Optum is reportedly acquiring AbleTo for $470 million which provides behavioral telehealth — looks like they’re slowly putting all the pieces together to become a big virtual Kaiser. —Matthew Holt
With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team: