Public consultation of the EU Commission on Transformation of Health and Care in the Digital Single Market

As part of its Digital Single Market (DSM) Strategy, the EU Commission has launched a Public consultation on Transformation of Health and Care in the Digital Single Market. The consultation is accessible here, and the deadline for responses is 12 October 2017.

The Digital Single Market Strategy

Aimed at maximizing the positive impacts of this digital revolution on people's lives and European business activity, as one of its 10 priorities, the EU Commission adopted the DSM strategy at the beginning of its current four-year term in May 2015 (see this link). In the two years since the adoption of the strategy, the EU Commission has made 35 proposals and initiatives on 16 key measures (see overview here) to create a stable legal environment, stimulate innovation, tackle market fragmentation and allow all players to tap into the new market dynamics under fair and balanced conditions. Through improved access and fair conditions, the DSM strategy shall achieve an open market where it is easy for businesses and people to operate as effectively anywhere in Europe as it is at home.

Having reached the middle of its mandate, the Commission published the mid-term review of its DSM strategy on 10 May 2017 (find more information here). It takes stock of the progress made, calls on co-legislators to swiftly act on all proposals already presented, and outlines further actions, including a proposal that the Commission adopt in 2017 a Communication addressing the need and scope for measures on digital health and care, in line with legislation on the protection of personal data, patient rights and electronic identification, particularly:

• Citizens´ secure access to electronic health records and the possibility to share these across borders.
• Support data infrastructure to advance research, prevent disease and personalise health and care in key areas.
• Facilitate feedback and interaction between patients and healthcare providers enhance disease prevention and empower people to take responsibility for the management of their own health.

Digital Healthcare

The healthcare sector is undergoing a fundamental transformation, with technologies such as the Internet of Things, robotics, data analytics, augmented and virtual reality and artificial intelligence set to revolutionize diagnostics and treatment of patients. According to the EU Commission, demographic change, increased longevity, the rise of chronic conditions and the re-emergence of infectious diseases combine into a major challenge for health care provision in Europe, and digital technologies can offer cost-effective tools to support the transition from a hospital-based health care model to a patient-centred and integrated model, improve access to care, and contribute to the sustainability and resilience of healthcare systems.

The consultation

As described by the EU Commission, the purpose of the consultation is to define the need and scope of policy measures that will promote digital innovation in improving people’s health, and address systemic challenges to healthcare systems, respective policy measures to be aligned with legislation on the protection of personal data, patient rights and electronic identification.

The consultation seeks to collect information on:

• Cross-border access and portability of personal health data
• Sharing of resources (scientific research expertise, data capacity and advanced digital infrastructure) that will accelerate research and advance prevention, treatment and personalized medicine; initially in three areas:
  • rare and complex diseases in order to facilitate the transfer of knowledge from the laboratory to the clinical setting;
  • preparedness for upcoming epidemics and EU-wide identification of infectious threats within days;
  • the use of real world data for the purpose of pharmacovigilance and assessment of effectiveness of products placed on the market.
• Measures to ensure widespread uptake of digital innovations, enabling more patient centered and integrated healthcare, and allowing for feedback and interaction between patients and healthcare providers.

Participating in the consultation

The consultation is open for any interested party, including health and social care professionals and organizations, manufacturers and service providers of digital health solutions, research organizations, hospitals and the service and Internet of Things industry.

Responses can be submitted in any EU language through an online questionnaire available here. Please note that the EU Commission reserves the right to publish all contributions to the consultation, unless non-publication is specifically requested in the general information section of the questionnaire.

The EU Commission shall publish a short summary of the consultation results within 1 month after the consultation closes, and issue a synopsis report with a qualitative analysis of all consultation activities within 3 weeks of the closing data of the consultation.