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:
A few months ago, a young cardiologist told me that he rarely listens to hearts anymore. In a strange way, I was not surprised.
He went on to tell me that he gets all the information he needs from echocardiograms, EKGs, MRIs, and catherizations. In the ICU, he can even measure cardiac output within seconds. He told me that these devices tell him vastly more than listening to out-of-date sounds via a long rubber tube attached to his ear.
There was even an element of disdain. He said, “There is absolutely nothing that listening to hearts can tell me that I don’t already know from technology. I have no need to listen. So I don’t do it much anymore.”
I began to wonder. I called my longtime friend and colleague, also a cardiologist. I knew him to be one of the best heart listeners. I asked him if he still listens to hearts. He answered, “Of course I do. I could not practice medicine if I didn’t. But you know every week, several patients tell me when I listen to their hearts that I am the first doctor ever to do that. Can you imagine that?”
Playing the devil’s advocate, I challenged my friend to tell me what he learned from listening to hearts.
He answered, “How could anyone not want to hear those murmurs, sometimes ever so soft, like whispers? Murmurs from the heart, even very faint ones, are trying to tell us significant things. Some sounds are very localized, even hidden or obscured by layers of air. And then there is the rhythm and the beat and the cadence that you cannot hear on the paper strip of the EKG. Also, careful listening is the only way to appreciate the rubs of friction if there are any. The devices are important, but the heart has its own spoken and unspoken language if you know how to listen.
The American Board of Internal Medicine (ABIM) and nine other professional medical societies announced that doctors should perform 45 tests and procedures less often than currently done because there is no good medical evidence that they add any value. Specifically, a xray or other imaging for low back pain in an otherwise healthy individual or an EKG as part of a routine physical, just add a lot of unnecessary cost to the health care system as a whole and don’t provide doctors or patients any meaningful information that would be helpful in improving health or arriving at the right diagnosis and treatment.
The ABIM partnered with Consumer Reports to create a new campaign called Choosing Wisely and are joined also by collaborators like employers (the National Business Group on Health, the Pacific Business Group on Health), hospital safety (the Leapfrog Group), and labor unions (SEIU). The mission is simply to have doctors and patients deliver and receive care that is medically necessary, based on evidence, avoids harm, and minimizes duplication.
The real question is – will it work? Will doctors follow what their professional societies recommend?
Though Choosing Wisely is a laudable attempt to make medical care better quality, the truth is doctors won’t likely follow these guidelines from their medical societies. If it was that easy, we would not have this problem! Even today, it is still a challenge for the medical profession to have all doctors wash their hands correctly every patient every time, get immunized routinely against influenza, or even not to prescribe antibiotics for coughs, colds, and bronchitis due to viruses! What is more disturbing is that doing these basic interventions did not impact a doctor’s income. Some on the list of Choosing Wisely, however, will.