Digital health: rise of the machines

Healthcare is getting personal.

Just as a greater understanding of genetics paved the way for a revolution in medicine, making made-to-measure treatment programmes a reality for many patients, advances in technology are sparking another revolution.

The big technology players—such as Apple, Samsung and Google—are putting smaller, more powerful devices into the hands of many, and creating infrastructures to store our data.

Combining the data generated by wearable technologies such as the upcoming Apple iWatch and Fitbit’s wristband products, which track our vital signs, with the analytical capabilities of smartphones can bring about a greater understanding of our overall health.

In a phenomenon coined ‘the internet of things’, our devices can talk to each other via apps and alert us to any issues, even connecting with our healthcare providers.

According to figures quoted in a law firm Pinsent Masons Winter 2013 report, by 2015 an estimated 500 million smartphone users worldwide will be using a healthcare application.

With our smartphones acting as our personal doctors, digital health offers an incredibly efficient approach that can cut healthcare costs and reduce the failure rate of one-size-fits-all treatment programmes.

However, what are the protections available for the systems behind digital health, which occupies an intersection of biology and software?

Wearables

Many sufferers of diabetes have to check their blood sugar before mealtimes by pricking a finger using a lancet carried in a blood monitoring kit, which can be cumbersome and inconvenient.

Wearable technologies such Google’s contact lens, which measures the levels of glucose in tears, offer a solution that would fit seamlessly into daily life. Healthcare innovation expert and inventor Daniel Kraft has suggested that Apple’s iWatch will track blood pressure and heart rate, with later innovations by the company eventually monitoring blood sugar as well.

Among the big tech players at least, competition is fierce, so what are the options for protecting their digital health services, which consist of devices, software and data?

For the medical devices themselves it can be fairly straightforward—they are inventions that can be protected by patents. But for the software digital health services run on, as well as the information that they generate, it is not so clear cut.

Applying for patents to cover components of the digital health network is not simple. “There are patent thickets out there which, particularly when you’re talking about connectivity and things like that, need to be negotiated around,” says Allistair Booth, a partner at Pinsent Masons LLP in London.

“Basic patent law hasn’t changed, so there will still be difficulties in some jurisdictions in obtaining patents for software which could, or could not, be an integral part of the offering.”

Matthew Warren, a partner at Bristows LLP in London, identifies three key areas to consider, only one of which concerns IP. “There’s also a technical side,” he says.

“You have to secure the data. If you want to stop people stealing it you’ve got to get the technical measures in place,” he says, adding that there are issues of data protection and privacy rights to negotiate.

Tamara Fraizer, a principal at Fish & Richardson in Silicon Valley, says the IP issues are “tricky”. “Considering the convergence of several related areas, it’s quite fascinating, but it’s also challenging.”

Fraizer says the significant challenges for protecting digital health innovations will be posed by inventions focused on information processing. The information produced by medical devices holds a lot of potential for innovation in processing, but “IP systems are not really directed to protecting information per se,” she says.

Where the Myriad decision last year gave us guidance on what can or cannot be patented in a genetics context, the US Supreme Court’s ruling in Alice Corporation Pty v CLS Bank International will guide what’s eligible for patenting in software, a decision that will also have an impact on digital health, as many services rely on the software they operate on.

“The software itself is not going to be quite as eligible for patenting, so the real challenge is finding a focus for these innovations in the real world,” Fraizer says.