Early adopters’ minimum criteria for success

To comprise at least seven and no more than ten members, with stakeholder representation from at least all categories directly relevant to the App Label:

  1. One Member State assessment body, advising on continuing fitness of labelled Apps for fast-tracking through national assessment systems
  2. One Member State HTA body, advising on the evaluation and approval of digital health apps
  3. Two representatives of reimbursement bodies or other procurer organisations, one of which an EU-level organisation, advising on the continuing trust in labelled Apps
  4. One Medical/scientific professional association, advising on continuing Label and Label documentation value for health professionals
  5. Two Patient and citizen organisations representatives, advising on continuing Label and Label documentation value for patients

Nominations to join the Advisory Board may be received and considered at any time.

The initial members will be appointed by the Governance Board, on the basis of a short CV and declaration of interest form. Subsequent appointments to enlarge the board or to replace outgoing members will be made by the existing Advisory Board, aiming to be inclusive of and achieve balance across the intended stakeholder group constitution.

All Advisory Board members will produce and maintain annually a declaration of interests and will normally have a term of three years.

Meetings will be held at minimum every three months, and may take place in person, virtually or hybrid.

Where necessary, specific agenda items may be discussed under Chatham House rules i.e., participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed.

No formal quorum is defined. Invitations will be sent at least three weeks prior to the meeting. The timing of the meetings will be selected as to accommodate the availabilities of at least 60% of the members. 

The minutes and recommendations from the Advisory board will be received and actioned by the LabelDigitalHealth Network, which may refer matters to the Governance Board in cases where a formal decision is required.

A summary of the main topics considered by the Advisory Board, excluding confidential details, will be published on the web site of the LabelDigitalHealth network webpage.

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