Is the device validated?

Is the device validated?

The Food and Drug Administration (FDA) approved the device proposed by Apple, and Commissioner Scott Gottlieb announced the agency’s desire to “work with the technology industry to promote innovations in digital health.” These are important details, and Apple remembers that it is keeping confidential: if the same hour is commercialized as of September 21, it is expected that the ECG will be implemented before the end of the year in the United States, only in the United States. To measure the pulse of the rest of the world, including France, Apple will first get the whiteness of the local health authorities.

At present, no scientific studies have been published after validation of the  device and the algorithm that accompanies it. The Food and Drug Administration (FDA) adopted its decision to study (small), an Apple study Rapid Tone on the heart conducted by the company with Stanford University in a population of 588 people, half of whom which suffers from atrial fibrillation. Surveillance was able to identify 98% of patients and 99% of healthy people, but a cardiologist could not read 10% of the lines, according to US media.

»Read also – 101 good practice rules for” health applications ”

• Is the ECG for everyone useful for something?

Atrial fibrillation affects less than 1% of people under 60, but 10% after 80 years. But the oldest is not exactly the main object of connected objects, which, although dedicated to health, are used to a certain extent by young and active populations. Some people wonder about the usefulness of this system for residents, do not worry too much. “It may be interesting for someone who feels, for example, intermittent palpitations, not necessarily appear in the presence of a cardiologist, who can not record anything.” I treat a patient who came with his own pattern that showed turbulence in the rhythm, “says Dr. Amara.

But a systematic electrocardiogram in a non-transient group is not useful, according to several recent studies. North Carolina researchers took 3 tests in a total of 18,000 people, at the beginning of August as a population at risk of atrial fibrillation, but without symptoms, the ECG has not been traced through a simple FA pulse taken by a doctor. As for the US Preventive Services Rapid Tone Australia Task Force. US, A US agency is responsible for making recommendations on the effectiveness of preventive care for non-accidental patients and failed in June 2018 “against the practice of ECG prospecting or at rest in adults without symptoms with low cardiovascular risk”, estimating that the benefits were not While the real risks are clear, including those related to possible invasive measures conducted by a questionable ECG.

• Risk of unnecessary treatment?

“You must be careful not to lead to unnecessary consultations or undue concerns,” says Dr. Amara. “We can treat coagulation (and thus expose bleeding) in patients who will not need” concerns on their part, Dr. Florian Zores, a cardiologist in Strasbourg and a member of the heart failure and cardiomyopathy group of the French Society of Cardiology. “There are signs, which combine many risk factors, which let us know if it is useful to put the patient on anticoagulants,” and whispered to Walid Amara. “If it helps to diagnose more encephalitis and prevent strokes, I will not hesitate to apply an anticoagulant to a patient, but, on the other hand, intervene to restore the heart at a constant rate if the patient does not feel any symptoms, it may not deserve. ”

• For the doctor, interest or risk?

Apple Watch is proud to allow the recording and sending of collected data to the user’s physician. “30 Apple Watch email receipts, can not study or discuss directly with patients, the need to handle the concerns of people on the phone … Who will?” Descoux Jesuits scream, who fear the flow of anxious patients, because they can already be through irregular heart rate measurements sometimes made by some associated objects. Walid Amara is less worried: “I have not seen an increase in inquiries about this.”

In summary, these self-measuring devices may be useful in patients with symptoms, such as palpitations. But apart from these particular cases, “this does not respond to the great need for public health,” experts estimate.

The question of the possible legal consequences of these regulations remains: if the patient suffers a heart attack, what about the responsibility of the doctor, who reassured his patient by mistake but in fact did not have a “vision” of this deficiency?

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