Interview with Pēteris Zilgalvis: Take Digital Health Services to the Citizens

27th May 2015

mHealth is a bottom-up movement, but questions of quality assurance and organisational barriers, stand in the way of citizens being properly empowered in its use. This is restraining potential the technology holds to increase affordability and accessibility of health care, says Pēteris Zilgalvis, Head of Unit, eHealth and Wellbeing, DG Connect

The technologies to underpin the digital transformation of healthcare are on hand, but structural and cultural barriers stand in the way of wholesale implementation.

Indeed, healthcare, more than any other sector has found it difficult to come to terms with the change management required to reshape processes in preparation for the adoption of technologies, including eHealth, mHealth, telehealth and assisted living.

Along with process change it has been necessary to grapple with issues including re-skilling, protecting patient data and getting operational silos and silos of information to interoperate.

The European Commission has been active in helping member states to deal with these digitisation issues, in initiatives including the Connecting Europe Facility, in which a cross-border infrastructure will be set up to enable the transfer of health records, health summaries and eprescriptions; agreeing a memorandum of understanding with the US to promote standardisation and interoperability in eHealth; ensuring the new regulations on data protection and medical devices are in line with the overall objectives of bringing digital platforms to bear in healthcare; and in fostering the development of mHealth.

“Obviously, health is an area of subsidiarity and it is up to member states whether to implement digital technologies. The Commission wants to provide support and encourage the operation of a single market in these applications, products and services,” says Pēteris Zilgalvis, Head of Unit, eHealth and Wellbeing, DG Connect.

mHealth creates impetus for change

While moves to apply information and communication technologies to healthcare date back over at least three decades, the rise of mHealth has brought significant new impetus to these efforts.

The publication of a Green Paper and public consultation on mHealth in 2014 were important milestones in the Commission’s push to establish a single market for mobile health apps. Amongst the issues to be addressed is the gap between consumer apps and the ability of healthcare systems to interact or act on any outputs; the many questions around assuring the quality of health apps; and the level of oversight required to ensure apps are safe.

“The main areas that came up in the consultation as being in need of attention are trust and security,” Dr Zilgalvis said. The Commission is now working with industry to draw up a code of conduct to ensure confidentiality and security in mHealth. This will be fully in line with the new data protection and medical devices regulations. “I’m now optimistic this can be completed by the end of the year,” said Dr Zilgalvis.

Dr Zilgalvis outlined the requirements in terms of evidence, validation and certification of mHealth apps, at the recent eHealth conference held under Latvia’s Presidency of the EU. The conclusions of the consultation on mHealth were published at the same time.

EU to take a coordinating role

There are no plans to set up a central agency to certify mHealth apps. “It’s not realistic to have a system of pre-market certification. It would slow things down and wouldn’t achieve the aim of promoting prevention and empowering people to take responsibility for their own health,” Dr Zilgalvis said.

Instead, it is suggested that the EU could help to coordinate a network of the existing testing bodies, including national regulators, charities and patients’ groups. It will be important to ensure there are mechanisms for removing unsafe apps from the market, but Dr Zilgalvis believes this could be achieved with existing consumer protection laws.

The Commission is also taking action to bridge the divide between the outputs of mHealth apps and patients’ formal medical records, publishing a call for proposals for research projects to look at cybersecurity in mHealth, interfacing to medical records and mHealth apps in cross-border healthcare.

“We won’t make the decisions about linking mHealth and traditional records, but if there are reliable apps and ways of doing it, if you can get good information from apps, then we think this will drive the integration of mHealth and medical records,” said Dr Zilgalvis.

Reflecting on how things are going overall, Dr Zilgalvis said, “I’m pleased to say, I think we are making progress in overcoming the barriers to the more widespread introduction of mHealth.”