Model Christy Turlington Burns picks up an Apple Watch yesterday (Image: Getty)

    The Apple Watch could have been a proper health-monitoring device. But the FDA won’t allow it

    10 March 2015

    Apple’s new smart watch, unveiled by Tim Cook yesterday, had incredible potential. But its functionality has been hindered by technical hitches – and, especially, overzealous legislators. Their cloying presence must have been felt at every product meeting. Engineers working on Apple’s watch did so with the rasping breath of the US Food and Drug Administration (FDA) on the back of their necks.

    The result? Apple is nowhere near giving us a device that allows comprehensive self-monitoring of health – thanks to federal regulations. Public health services everywhere tell us that prevention is better than cure. But the FDA doesn’t trust Apple, or any manufacturer of wearable tech, to gather the sort of intimate and precise medical data that could actually prolong your lifespan. It has modified its regulations specifically to allow wearable tech to monitor ‘general wellness’ – but for now anything more probing (or intrusive) is out of the question.

    This is hugely frustrating for Apple. In a locked drawer somewhere in Cupertino, there is bound to be a blueprint for a simple and engaging device that would have normalised intensive self-monitoring of health. Apple strategists have been keeping a close eye on devices such as Carunda24, which has the capacity – but not the legal permission – to monitor, display and store your blood pressure stats.

    Here’s what Carunda24 claims to be able to do:

    Today there are a several systems which deliver a variety of data, but only very few in the field of blood pressure. The well-known and widely used heart-rate-monitors show only one aspect of the pulse and not the whole pulse-wave.

    [Our watch] solves this problem. The continuous, non-invasive measurement of the pulse wave provides you and your physician or health-care professional not only with blood pressure (diastolic and systolic) but also critical information about the quality of your pulse including the number and regularity of your heart-beat and the rate of increase in blood pressure.

    But scroll down the page and you hit a wave of caveats and disclaimers:

    Even after a successful ‘proof of concept’, the road from clinical prototype to a commercially deliverable system is still full of challenges, which may be of a technical nature (as CARUNDA24 uses a new method which still has to be subjected to extensive testing) or in the validation process where unknown questions may arise.

    The bottom line: the makers of wearable health apps are a long way from securing approval for technology – much of it already developed – that could not only save millions of lives by measuring vital signs but also give us control of our bodies in other ways. Of course it has to be tested, and that takes time – but that’s nothing compared to how long it takes to secure bureaucratic approval.

    Consider natural contraception. The fertility awareness method (the rhythm method updated for the 21st century) currently requires a strict regime of note-taking and temperature measuring. Yes, it can be done the old-fashioned way, but a dedicated device costs £400. A simple thermometer attachment and an app that could be written in minutes could prevent – or facilitate –thousands of pregnancies.

    Make no mistake about it: these gadgets are coming. But not yet. Maybe not even soon. And until then the future of ‘personalised medicine’ hangs in the balance.

    This week Apple was keen to tell us what a huge stake it has in this market. It’s launched an initiative called ResearchKit which, reports the Guardian, ‘will provide apps to help patients share data on conditions including breast cancer, asthma, Parkinson’s disease, diabetes and cardiovascular disease with medical researchers’.

    That’s nice, but it’s not earth-shattering in the way that a state-of-the-art health monitoring wearable device would be. Yesterday Tim Cook tried to tell us that the Apple Watch was that device. It’s not. It is a fashion accessory. A hotel key card. A garage door fob. Anything apart from a useful health product. More’s the pity.