Digital health Revolution: Doctors of Data - Annual Review 2015

This article was produced by Olswang LLP, which joined with CMS on 1 May 2017.

This article is an extract from our Annual Review 2015.

The convergence of life sciences and technology heralds a 'digital health' revolution with the potential to reshape consumption of healthcare services, transform government policy and minimise disease risk by enabling health-focused lifestyle choices. Are our legal and ethical frameworks ready for the transformation?

By Robert Stephen, Stephen Reese

The healthcare industry has long understood that a 'one-pill-fits-all' approach is an inadequate way to treat billions of individual patients across a multitude of genetic, cultural and environmental backgrounds. It has therefore attempted to work towards an idealised vision of personalized medicine, whereby the right drug is delivered to the right patient, atthe right time, in the right dose. However, the ability to derive and collate the individualised data necessary to deliver on this vision has, to date, been a limiting factor.

The advent of personal genomics provided a significant step towards enabling personalised medicine, but it is innovation in wearable and implantable devices capable of measuring a multitude of personal biochemical and physiological parameters that will deliver on genomics' promise.

Wearable technologies such as the Samsung Gear and the Apple Watch are marketed largely as lifestyle products, with apps aimed at measuring and improving health- and sport-related activities. However, these products are also part of a new category of medical devices capable of monitoring all the vital bodily functions in real time and transmitting this data via wireless networks and mobile phone technology to a cloud storage facility for diagnostic purposes.

Devices are now available that can, in a non-hospital environment, measure and transmit all of the same categories of health markers that would currently be measured in an intensive-care facility. These products include earphones that can check blood-oxygenation levels, edible microchips that can capture food intake and rest patterns, and even nanotechnology-enabled sensors, or 'nanobots', which can be injected into the bloodstream; there, they wirelessly transmit data regarding the presence of markers that can help to predict diseases such as cancer or heart failure.

The benefits of harnessing device technology in this way are beginning to influence the collaborative and acquisition strategies of the major pharma companies, which are looking at complementary diagnostic partners that have the technology to transform their therapeutic innovations. These companies' ultimate commercial goal is to deliver integrated diagnostic and therapeutic products under a single brand.

The connectivity of wearable devices is relevant not only to the uploading of data for diagnostic purposes, but also to delivering information to the user to improve their use of healthcare services and products. A vast amount of public money is wasted as a result of patient non-compliance with medication regimens. The impact of medication-reminder apps, for example, which prompt patients to take their pills and connect to a pharmacy to refill prescriptions, could have a sizeable impact on reimbursement arrangements and the strategies of pharma companies.

Among the health apps in the NHS library is Sleepio, a program that delivers personalised cognitive behavioural therapy for insomniacs, which won the Wired Health Bupa Startup competition.

In developing countries, the ability of smartphones to capture patient data could also have a powerful impact on national vaccination programmes. Tracking each vaccinated individual via a barcode scan can facilitate an understanding of the stage at which sufficient individuals have been vaccinated, which can help to create effective immunity for the whole population.

Detecting, reporting and collating vast amounts of individuals' biological and physiological data also provides great opportunities for the biopharmaceutical industry to improve the efficiency of its clinical trial and post-approval surveillance procedures. Many therapeutically effective drugs (Vioxx is a significant example) are not presently available because of serious negative side effects in a relatively small number of patients. The use of devices to constantly monitor for markers of the onset of such side effects will change the entire regulatory environment - and should ensure that many more important drugs reach and remain in the market.

Data privacy

The ability to sync wearable technology to a smartphone will allow people to create a hub of personal healthcare data that they, their GP and even their personal trainer can access.

Here, the issues of data protection and purpose become acute - individuals will want to use the data for their personal benefit, but what are the legal and ethical parameters guiding what employers or insurers can do with it? What happens when the line is crossed between information about wellbeing and information concerning matters of life and death?

This concern - of private medical records becoming a commercial proposition - goes to the heart of the debate over the UK's NHS care. Data programme to share and link patient data in order to improve research and "transform health services". In February 2014, the scheme was delayed by six months in order to "ensure stronger safeguards around the uses of the data [and] clarity about the rights people have to opt out".

Such gathering of data raises fundamental questions about privacy and ethics. The price of genetic information has fallen dramatically - from $10m per genome in 2001 to close to $1,000 - but the much publicized shutdown of 23andMe's home DNA-testing service by the US Food and Drug Administration demonstrates the difficulty of regulating consumer-driven medical research.

It is little wonder that legislators do not have the answers. The convergence between technology, life sciences and data is fast-moving, making categorisation and enforcement difficult. The world of wearable technology is not yet regulated. And with very little precedent, legal and commercial departments need experts with degrees in computing and biology. Engineering in the life sciences field is not new, but the internet has brought discovery much closer to the individual - and, with it, the need for doctors (and lawyers) who understand data algorithms.

"In 20 years, humans will finally attain the status of cars for their medical care. They'll have wearable and embeddable sensors with predictive analytics, and, most importantly, autonomous driving capabilities. Most cases of cancer will be successfully treated, Alzheimer's will be substantially delayed or even pre-empted. DNA sequencing will be performed for most individuals at birth (or as a foetus). Hospitals, except for certain key functions like intensive-care units and operating rooms, will be completely transformed to data-surveillance centres. People will look back and laugh about the old physical office visit and the iconic 'stethoscope' along with the way so much of healthcare was rendered in the pre-digital era." - Eric J. Topol, Chief Academic Officer of Scripps Health and Professor of Genomics at the Scripps Research Institute in California.

Click here to view an electronic copy of our Annual Review 2015.