| A1 |
Administration and communication supporter |
Business models around tools assisting with administrative tasks (eg, scheduling and report writing) and patient interactions Not medical devices; often using cloud, network technology, and artificial intelligence; efficiency evidence not typically provided Health care providers pay for these nonreimbursable solutions; interfaces are mainly mobile apps and web applications
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Automated medical report writing, appointment management tools, and telehealth video consultation |
| A2 |
Insurer-to-consumer digital therapeutics and care |
Business models around supporting digital treatment of medical conditions, used mainly by patients and private individuals Regulated as medical devices under the MDRb, providing mostly high clinical evidence (peer-reviewed studies) Focus on primary and secondary care, rely on health insurer reimbursement, and incorporate multimedia and patient-reported data; some act as support channels with the provider
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Mobile app for treatment support of leaky gut, depression, or overweight |
| A3 |
Diagnostic and treatment enabler |
Business models for solutions assisting physicians in diagnosis or treatment planning, sometimes including administrative support Regulated as medical devices under the MDR (medical imaging and physiological data) or the IVDRc (data derived from human biological materials) Used and paid for by health care providers; use artificial intelligence; feature mobile apps or web applications; do not facilitate stakeholder interaction
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Radiological imaging tools, treatment planning software, and in vitro diagnostic software to support the diagnosis |
| A4 |
Professional monitoring platforms |
Business models based on digital platforms to monitor patients’ medical conditions, connecting health care providers with patients and private individuals Classified as medical products under the MDR, supported by clinical evidence Facilitate interuser interaction; integrate administrative support, telecommunication, and education; primarily paid for by health care providers, sometimes reimbursable
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Physician platform to monitor progression of Parkinson disease based on mobile app and therapeutic exercise–monitoring platform |
| A5 |
Clinical research and solution accelerators |
Business models around the acceleration of clinical research or the provision of raw technology for pharmaceutical companies, medical technology companies, and research institutions Some solutions are classified as medical devices under the MDR, while research applications are not regulated Paid for by indirect health care firms and research institutions, may or may not facilitate stakeholder interaction and include developer tools as well as mobile apps and web applications
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Diagnostic tools based on artificial intelligence that medical technology companies can integrate and software to support clinical trial execution through data collection |
| A6 |
Direct-to-consumer wellness and lifestyle |
Business models enabling information delivery and education for patients and individuals, with some telecommunication features and marketplaces Not classified as medical devices Include coaching through mobile apps and web applications; sometimes provided by medical clinics; targeting self-pay markets and corporate wellness; some are reimbursable and report nonclinical evidence
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Mobile app for meditation, pregnancy support apps, and health and sports coaching mobile app |
