mhealth is transforming the healthcare landscape by revolutionising the way people interact with doctors and making healthcare services more efficient and accessible to more people. For life sciences companies these changes require a rethink of some of the traditional approaches to regulation, data protection and intellectual property.
Evolving regulations – does your mobile phone count as a medical device?
Any proposals to allow mobile access to patient data and records invariably throw up concerns around data security and privacy. The main challenge is making sure the underlying IT infrastructure is secure and that patient data privacy is properly protected. This will involve a combination of regulation as well as technological innovation. At the moment, there are no standards specific to mHealth and so auditing suppliers for data risk is a bespoke (but necessary) process.
The new medical devices regulations will clearly have an impact on the adoption of mHealth technology. The greater focus on post-market regulation and surveillance is likely to raise novel questions such as to what extent consumer devices or apps need a prescription. There is a danger in defining regulatory obligations too narrowly. This could be particularly significant where products have both medical and consumer related functionality – an example is a mobile phone which can be adapted to work as a heart monitor.
Many mHealth initiatives will be platform technologies (for example tele-health services) and will need to be integrated with existing IT healthcare infrastructure. It is therefore essential that companies take a long-term and a strategic view when entering into this space and that regulators focus on ensuring flexibility of infrastructure to allow patients long term choices of providers.
Different IP models – is traditional IP protection appropriate?
Companies also need to think strategically about IP protection and commercialisation. In certain cases, it may make more sense to adopt open source or open platform models – allowing others to innovate and develop solutions that will help drive up the value of the technology. This means that technology providers will not have to always “second guess” what patients want or the best way healthcare services should be delivered.
The fact that mHealth initiatives are likely to be largely funded by Governments and the healthcare insurance industry will require a rethink of the typical consumer-oriented licensing models. Companies will also need to find ways to tackle industry insiders who will strongly fight changes that they find disruptive to their own working practices.
Regulators’ enthusiasm versus doctors’ reluctance
The European Commission has recently published an e-Health Action Plan acknowledging that healthcare services delivery significantly lags behind other areas of IT innovation. To address this gap, the Commission has called for an aggressive action plan for reform. The Commission will also be releasing a study on interoperability of electronic health records later this year and a more comprehensive Green Paper by the end of 2014. The issue of mHealth is therefore firmly on the agenda for European governments and policymakers, and stakeholders will need to follow these developments closely to remain ahead of the curve.
Against this background of seemingly wide-ranging regulatory developments, there is the challenge that the healthcare industry is conservative. Even small technological developments can take a long time to get the regulatory stamp of approval. mHealth fundamentally redefines the long-standing social contract between doctors and patients. Patients using mHealth services will have more ability to actively take part in their own health management and treatment. In addition, the technology is still in its nascent stages and many of the regulatory issues have not yet crystallised. This contributes to doctors and patients being unwilling to use it and to concerns around product liability.
Written by Charles Waddell, Partner, and Indradeep Bhattacharya, Senior Associate, Life Sciences Team at Pinsent Masons, July 2013.
Pinsent Masons is an award winning international law firm focussed on providing a full range of services to clients in different industry sectors including life sciences and TMT. We have more than 40 senior Life Sciences industry specialists worldwide, with expertise in intellectual property, regulatory law, product liability, competition, commercial law, in & out-licensing, product & corporate acquisitions, tax and employment. We are also rated by the legal directories as a top tier TMT firm.
The One Nucleus blog is written by individuals and is not necessarily a reflection of the views held by One Nucleus.