Harvard frets on 40,000 unvetted health apps–should we?

The Harvard Health Letter rails on that there is still no ‘trusted provider’ or vetting of consumer health apps. It sternly wags its finger to us on lack of regulation and no proof, beyond user reviews or forums, of effectiveness. There was the promise of Happtique to ‘curate’ health apps directly for consumers which is either permanently or temporarily on hold. Health Tap still has not yet filled the gap [TTA 31 May]. According to the HHL, trackers and calculators are the safest road to this kind of information. The article turns a decidedly dim eye on diagnostic tools such as phones for telederm consults. Consumers also should look at the brand–who produces the app, how often the app is updated, and if it provides references for the information it offers. The rest of the advice is fairly standard: consumers should buy well-known health brands, such as government agencies and research universities, and non-diagnostic usages. Hopefully most consumers will get the picture and we won’t have to fret on them. Some health-related apps should be avoided (Chicago Tribune.)

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  1. The reason why this is important is because it is about patient safety.. and mitigating risk that a device (or advice from a device including an app!) could do harm to a patient either by “misguiding” a patient or changing the diagnosis/intervention that places the patient at additional risk or possibly in real danger. The medical device world is rich with legislation and standards to mitigate these risks by following good practice (GxP) and the appropriate ISO standards etc. under the quality management governance of a company’s QMS – all of which are required to be the legal manufacturer of a medical device placing a medical device product on the market.

    If you don’t understand this, you should seek professional advice as placing a medical device on the market without conformity assessment/market authorisation is illegal.. even if it “free”. The regulators will be looking for some high profile law breakers to amplify their message ( with prosecution and large fines) – as well as seeking out small companies who have illegally brought product to market who they will ‘red letter’ to get the product compliant or removed from market.

    On the mobile app front, what is going to be fascinating to watch is the attitude that companies with large scale app distribution (iTunes, Android Apps, Windows App Store etc) have when this starts to get really messy and the lawyers get involved; distribution organisations are integral to the supply chain of the medical device to the end customer as they are the point of “sale” –so are they responsible for ensuring that the product they are selling is both legal (duty of care) and do they hold potential massive liability if a product they “sold” does harm to a patient?