Apple (and everyone) needs harmonized digital health regulation

Has Apple lived up to its promises on digital health? Perhaps not, but perhaps this is because we lack international standards for digital medical technology.

A heavily regulated space

Digital health is, rightfully, a heavily regulated space. Those who build solutions in that space must prove their products do what they claim. An easy way to see it is that while you can say apps and services may be of use for overall health, you can’t say they will make a difference — unless you can prove that claim.

What makes this more difficult is the lack of an internationally agreed upon set of standards around the space. There is work going on to create something, but it seems to be a very long process. The ITU and WHO in 2019 introduced a new global standard for safe listening devices (H.870). The UK, Canada, and Singapore are working together on the development of a common regulatory approach. All the same, digital health standards remain fragmented on an international basis.

That’s a problem for a mass market global brand like Apple.

That ECG thing

Think back to when Apple introduced ECG/EKG readings on Apple Watch. The lack of regulatory harmony meant the feature launched first in the US and then only slowly became available in other markets.

At this stage, it seems clear Apple Watch is part of the plan Apple has for health and that it remains heavily invested in digital health research to realize its ambitions. But there is another challenge: consumers won’t want to pay a premium for health features they don’t need.

Copyright © 2022 IDG Communications, Inc.

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