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:




There are 900,000 people in the United States who reside in assisted living settings, at an average age of nearly 87. On average, these individuals pay privately between $3,000-$6,000 per month for services that often include room and board, medication delivery and pill box set-up, supervision, and assistance with activities of daily living. Assisted living facilities are an integral part of the health care delivery system for many of our nation’s frailest older adults. Despite the high quality care that is often provided, the assisted living environment can often leave healthcare providers scratching their heads about what they can and cannot order for their patients. My recent experience with such a facility involving a patient with possible influenza illustrates the complex middle ground these facilities occupy.


