Digital health solution providers, and users of digital health services, should take note of three recently launched EU public consultations in the digital health space, and may wish to make submissions to help shape the future of digital health initiatives in the EU.  The earliest deadline for submissions is 16 August 2017.

EU Commission Transformation of Health Care in the Digital Single Market Consultation

On 20 July 2017, the European Commission launched a consultation on the “Transformation of Health and Care in the Digital Single Market”.  This Consultation covers three broad areas:

• Cross-border access to and management of personal health data.

• A joint-European exploitation of resources (including digital infrastructure), to advance health research, disease prevention, treatment and personalised medicine.

• Promoting the uptake of digital innovation to support citizen feedback and interaction between patients and health care providers.

Submissions to the Consultation close on 12 October 2017.

Consultation results will feed into a European Commission policy document known as a “Communication”, which is expected to be announced by the end of the year.

EU Commission Communication on Digital Transformation of health and care in the context of the Digital Single Market Roadmap

On 19 July 2017, the European Commission published a roadmap outlining the European Commission’s intentions for Communication.  The roadmap aims to:

• Enable citizens’ secure access to electronic health records and e-prescriptions and the possibility to share them across borders when traveling, working or living in another Member State.

• Advance research, disease prevention and personalised health and care in key areas by enabling access to data sets and medical expertise across borders.

• Promote widespread uptake of digital tools to facilitate patient feedback and better interaction/cooperation between citizens and healthcare providers, leading to better health care services and empowered citizens.

From the roadmap, it does not look like any legislation is anticipated (e.g. there is no reference to an “e-health Directive” that would provide for a pan-EU basis for secondary use of patient data).  The roadmap is also silent on the European Commission’s wider free flow of data legislative intentions.  The Commission is accepting feedback on the roadmap until 16 August 2017.

EU Presidency Digital Health Society Consultation

Finally, we note that the Estonian Presidency of the Council of the European Union has also launched a brief Digital Health Society consultation.  This consultation includes questions relating to whether citizens are sufficiently informed of the benefits of the sharing of data for health care services or research, ensuring there is adequate precaution to guarantee the privacy, confidentiality, and security of data, and interoperability challenges.  This consultation is open until 30 August 2017.

Getting involved

Interested parties, including digital health solution providers, operators and users of digital health tools, public authorities, hospitals, insurers and researchers and research institutions should consider making submissions to these consultations help shape digital health policy in the EU on wide-ranging matters including data privacy, medical device and healthcare regulation, and consumer rights.