A man tries out a generic but modern looking touch screen smart-watch on his wrist, his finger tapping the home screen to make a phone call or send a text message. Horizontal image.

    This ‘lab on a chip’ knows when you’re ill before you do. Will the regulators approve it?

    23 June 2017

    Good news for health obsessives and hypochondriacs; there’s a new personal health monitoring device that knows when you’re ill before you do. This week, engineers from Rutgers University revealed a chip that can identify serious health problems by analysing the contents of blood and sweat.

    The ‘lab on a chip’, which is small enough to be placed in a wearable device like a Fitbit, detects the biomarkers of various diseases with ’95 per cent accuracy’. The developers say it will soon provide readings that are 100 per cent reliable.

    Unfortunately there’s a snag. The overzealous regulators at the FDA probably won’t allow it to be sold to the public. To make it on to the mass market, the device would need to be approved by the agency.

    The US Food and Drug Administration, which is supposed to protect and promote public health, is extraordinarily reluctant to allow progress in this area. Two years ago the Apple Watch, which Tim Cook called the ‘Holy Grail’ of health monitoring, was hamstrung by FDA regulation. Now it’s little more than a glorified Casio.

    In an interview with Bloomberg, the FDA’s associate director for digital health, Bakul Patel, said: ‘If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.’

    But he was only referring to products that focus on fitness. Diagnosis is a different matter.

    ‘A lot depends on how the device is marketed. If a company is promoting a product to assist doctors in making medical decisions, it will require more oversight.’

    More oversight, in this context, means it’s not going to happen. That’s a shame, because public health bodies are constantly emphasising the importance of ‘preventive healthcare’, which is exactly what this technology would facilitate. A device that allows people to monitor their own health – and spot serious conditions early – could conceivably save thousands of lives.

    If the device isn’t approved in the US it’s unlikely to be manufactured at all. The importance of the American market means that the influence of the FDA is global. The fate of the Apple Watch, and other health monitoring technology like the Carunda 24, suggests that co-operation won’t be forthcoming.

    Why is the FDA so reluctant to rubber stamp consumer health monitoring technology? Essentially they are concerned about two things: data protection and the potential for misdiagnosis.

    Malfunctioning devices could give out false positives, leading to expensive lawsuits. But since this is a regular occurrence in the US anyway, it seems like a risk the insurance industry would be only too happy to take.

    Apple and other developers are keen to test and hone their products, and there is an eager public willing to throw money at them. Growth in the market is forecast to increase 35 per cent by 2019, according to a report in Business Insider.

    This overbearing attitude is characteristic of the FDA. E-cigarettes are a case in point; they are less harmful than traditional cigarettes, and it’s well established that they help smokers quit. But the threat of regulation hangs over that technology, too.

    We now have the ability to create sophisticated personal health monitoring devices. The technology is beginning to mature, but we are yet to see it appear on high street shelves. The regulators need to catch up, and quickly.

    This technology promises things that were unthinkable just ten years ago. In the decades to come we may well look back and wonder why it was kept from us for so long, and why regulators are stubbornly standing in the way of progress.