Start-ups or SMEs that:
- Work in the area of digital health
- Are a for-profit SME according to the EU definition
- Are incorporated in EU or Horizon Europe associated countries
- Got incorporated between 1 January 2015 and 22 March 2022
- Have at least two paid FTEs at the time of submission and a CEO working full-time in a company
- Have a digital health app CE-marked solution classified as a class I or IIa medical-grade solution under MDR or MDD – with a plan for MDR certification
- Plan to enter and get reimbursed in one market with novel reimbursement pathway in the next 6-18 months
- Meet requirements for reimbursable app in the targeted market
- Achieved initial traction on domestic market
- Have a digital health app solution with minimum IML 8 in all four domains according to CIMIT Healthcare Innovation Cycle
The following activities will be supported:
- Clinical trial design and evidence generation
- Compliance with regulatory requirements
- Pricing and business models development
- Training for healthcare professionals