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20 June 2014Biotechnology

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.

"if you can’t protect your business method with IP laws then keeping it secret is really your only option."

“Fundamentally, the key is to integrate the innovation from information processing or natural discoveries with the device in such a way that you may achieve your business goals and protect that without running foul of the restrictions.”

Managing data

The data generated by devices within the digital health network, whether that be by wearables or shared via social media platforms, is the lifeblood of the digital health operation.

Apple’s new HealthKit platform, which is being rolled out with the company’s new operating system, will bring together health and fitness data from the user’s other healthcare apps and display an overall picture of health on a dashboard.

The data shared on social networks can also be a key component in digital health, as it can be used to give a real-time status update on a region’s overall condition.

In 2012, researchers at the University of Rochester in New York were able to model the spread of a ’flu outbreak in the New York area by analysing 2.5 million geo-tagged tweets, giving a far more accurate and relevant picture of the city’s health than the US Centers for Disease Control and Prevention’s weekly ’flu surveillance report.

Data can also be a means of protecting innovations. Fraizer says many pharmaceutical companies or institutions will accumulate and process data in order to make discoveries, in what she calls a “siloing effect”.

“They will make the discoveries and they will keep the data and the methods of processing it secret. It makes a lot of sense, because if you can’t protect your business method with IP laws then keeping it secret is really your only option.”

"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."

How to protect the highly sensitive data that wearable devices generate is a contentious issue. Apple says that it stores the HealthKit data it collects in a “centralised and secure location” and that users can decide which data are shared with the app, although different jurisdictions have their own rules on data protection.

“In digital health, one of the practical concerns, particularly with databases containing patient information, is how you secure those from a technological standpoint,” says Warren.

Under the data protection laws, personal medical information is deemed to be particularly sensitive, so legislation gives medical data the highest protection, he adds.

“There is a risk that if these devices connect to the internet, and the patients’ data is kept in the cloud or stored by the device manufacturer and is not secured, there will be major issues if the information is hacked or made accessible.”

There is an EU directive for database rights that was implemented at the same time across EU member states but the US plays by different rules, which could pose problems for the transferral of data from country to country.

“With any personal information that’s sent out over the internet, particularly medical information, one has to be really careful about how that’s secure and what it’s used for,” Warren says.

Coming out on top

With Apple and Samsung both announcing their healthcare technology platforms in the last few months, and household names such as Nike and Sony offering wearables to a wider market, digital health is on the brink of exploding, so how will the situation unfold?

Booth says that the technology will “surge way past IP constraints”.

“In my view, there’s going to be an avalanche of technologies heading into digital health, and at some point there may or may not be a terrific scrap about who owns what,” he adds.

For now, determining which companies will come out on top is anyone’s guess, but Booth says “there’s going to be an awful lot of first-mover advantage”.

With the world’s largest companies getting in on the act, can start-ups muscle in on the digital health revolution? Will the tech giants skew the competition?

“There’s likely to be a synergy between the efforts of the technology giants and the start-ups,” Fraizer says.

“The advancement of the giants is fostering innovation by all of these small companies—there’s a lot of room for innovation and that’s not necessarily going to come from inside the giants.”

Healthy competition among life sciences companies tends to benefit the patient but, in the case of digital health, it looks as though working together could also be for the greater good, and what could be more apt for a system that democratises healthcare?