How the European Commission is supporting innovation in mobile health technologies Nordic Mobile Healthcare Technology Congress 2015 Claudia Prettner, Unit for Health and Well-Being, DG CONNECT
Table of Contents i. mhealth market ii. mhealth transformation of health services iii. mhealth initiatives on: a) Privacy and security b) Quality and transparency c) Legal framework
90% of mhealth apps remain free 36 apps account for half of all downloads 165,000 mhealth apps available wearables as new trend number of mhealth apps increased over 100% from 2013 to 2015
mhealth app categories
How mhealth transforms the way health services are managed
Mobile devices allow to collect big amounts of data...
Green Paper on mhealth The Green Paper asked stakeholders for their inputs on how to overcome the main challenges to mhealth deployment, e.g.: data protection the legal framework patient safety mhealth s role in healthcare systems international cooperation and web entrepreneurs' market access
Privacy and security Quality and transparency Legal framework
Privacy and security
Results of the consultation - Privacy and security Strong privacy and security tools are needed to build users' trust Data encryption both "in transit" and "at rest" Authentication mechanisms, e.g. digital certificates, biometric parameters, tokens etc. User's consent and access controls are crucial Importance of secured networks settings to prevent data interception
Current lack of trust Source: Mobiquity, The Appification of Health and Fitness, April 2014
Actions: Privacy and security Action: Code of conduct on mobile health apps covering data protection and security principles; voluntary instrument; to be signed by mhealth app developers and possibly to be approved by the Article 29 Working Party; Legal basis: Article 27 of the Data Protection Directive; Objectives: Increased trust; Raising awareness and facilitating compliance with data protection rules at EU level; Competitive advantage.
Actions: Privacy and security Action: Code of conduct on mobile health apps Process: Industry code of conduct working group with the EC as facilitator. Next steps: Meeting on 7 December presentation of 1st draft. More info: http://bit.ly/1povxro Security Actions: ENISA project on security and resilience for ehealth networks and infrastructures Research & Innovation action under WP 2016/17 "Increasing digital security of health related data on a systemic level"
Quality and transparency
Results of the consultation Quality and transparency Need for certification schemes to assess mhealth apps Sharing and transferring best practices Importance of standards for patient safety Setting-up of (national) bodies to review mhealth apps
Actions: Quality and transparency Action: Guidelines for assessing validity and reliability of mhealth app data to be linked with electronic health records the guidelines could be used by public authorities, health care providers, professional and patients associations and others Action: Facilitate the development of a European standard on quality criteria for health and wellness apps providing guidance and principles for health and wellness app developers to follow throughout the app project life cycle (including development, testing, releasing and updating of an app)
Guidelines for assessing validity and reliability of mhealth app data A working group of various stakeholder organisations Civil society, academia, industry, public authorities Expertise: medical, health policy, health IT, standardisation, certification, patient empowerment, etc Mandate Draft the guidelines by the end of 2016 Consider and integrate input from all the stakeholders Public call for expression of interest open until 04 December 2015 Process open to all stakeholders via online consultations and open stakeholder meetings More information http://bit.ly/1iaps7p
Legal framework
Results of the consultation Legal framework Safety and performance requirements of lifestyle and wellbeing apps should be covered by legislation, soft law or quality labelling/certification Need to clarify the borderline between "medical" and "lifestyle and wellbeing" apps Need for strengthened enforcement of medical device and data protection legislation
Actions: Legal framework Unclear application of EU rules on medical devices Action: Revision of manual on borderline and classification and MEDDEV guidance (finalization after MD regulations adoption) Lack of protection in case of unsafe or defective digital products (e.g. lifestyle and wellbeing apps) Action: Making consumer protection and ecommerce legislation fit for new technologies
Thank you for your attention! claudia.prettner@ec.europa.eu