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Opportunity

Recommendations based on opportunity

Opportunity reflects the extent to which a situation is conducive to achieving a desired outcome. In this context it refers to the availability and accessibility of empowering solutions, as well as the involvement of people in the process. In this chapter, the priority areas with the main focus on the opportunity element of the AMO framework will be described. These priority areas are ‘Legislation’, ‘Integration and interoperability’ and ‘Quality standards and assessment’.

Legislation

Collaboration at European level for the harmonisation of national laws and regulatory frameworks for the secure exchange of health data, in accordance to the GDPR, and in relation to the interoperability of Member State electronic record systems and the implementation of the European electronic health record exchange format.

Recommendation 15

Study or adapt existing legal frameworks applicable to patient access, telehealth, mHealth and telemedicine in order to achieve people empowerment building on the work of the Member States and EU legislation, to identify “grey” areas that need to be clarified and gaps that need to be closed.

Recommendation 16

Develop a policy proposal to define a uniform regulatory framework for telemedicine as a recommendation to the European Commission for decision making.

Recommendation 17

Integration & Interoperability

Use proven funding schemes for co-creation of empowering digital health solutions between vendors and procurers to promote integration and interoperability at the point of development, making sure of the sustainability of the project once the funding runs out.

Recommendation 18

Create a European framework for integration of individual health information (PGHD) in EHR services and functions, able to submit health information by patient and HCP . This needs to be done in a secure way and complying with privacy regulations.

Recommendation 19

Quality Standards & Assessment

Endorse and implement CEN-ISO/DTS 82304-2 as the common framework for quality and reliability of health apps.

Recommendation 20

Establish a dialogue for an open exchange among those responsible for application libraries and assessment frameworks. Let the mHealth hub and involved people on 82304-2 study the minimal requirements for quality assessment on a European and a national level.

Recommendation 21

Establish follow up funding to enable and facilitate implementation of the common framework. Support and monitor uptake of the common framework and mHealth by healthcare authorities and providers and in efficient public funding (reimbursement), in line with the Digital Single Market communication.

Recommendation 22