Success Factors for Scaling Up the Adoption of Digital Therapeutics Towards the Realization of P5 Medicine.

Introduction: Digital therapeutics (DTx) can be a valuable contribution to the successful scale up of P5 Medicine (personalized, participatory, predictive, preventive, precision medicine) as they offer powerful means of delivering personalization and active patient participation in disease self-management. We investigated how the approval and adoption of DTx within health systems have been approached in five selected European countries and regions, with a view to proposing success factors scaling up their adoption. Methodology: Preliminary research established best countries or region candidates as being Germany, UK, France, Belgium, and the Spanish Region of Catalonia. The research was informed by a literature review, interviews with public bodies and industry, and a multi-stakeholder workshop to validate the findings and fill in existing gaps. Results: To authorize the use of digital technologies, the countries and regions passed legislation and developed policy instruments, appointed bodies to assess and certify the products and formalized mechanisms for permitting reimbursement. While DTx is not a commonly used nomenclature, there are digital health technology types defined that have similar requirements as DTx. Assessment and certification frameworks are usually built around the Medical Device Regulation with additional criteria. Reimbursement considerations often observe reimbursement of therapeutic devices and/or medicines. To be integrated into reimbursement systems, countries require manufacturers to demonstrate clinical value and cost-effectiveness. As there are currently very few DTx approved in practice, there is resistance toward clinical acceptance and organizational change, and change management is highly needed to integrate DTx into healthcare systems. The integration and secondary use of DTx data is not encountered in daily practice. Although some enablers exist, there remain technical and legal barriers. Discussion: DTx strategies should be considered as an integral part of digital health strategies and legislation, and specific DTx pathways with clear and transparent assessment and guidelines that balance regulation and innovation should be defined. To help manufacturers, countries should recommend and list methods that are widely accepted and ensure scientific robustness, aligned to the MDR requirements to support transfer of relevant and comparable data across countries. To facilitate rapid uptake of innovation, countries should add flexibility to the framework by allowing temporary market authorization to enable data collection that can support the clinical and socio-economic evaluation and data gathering phase. Certification should trigger rapid price setting and reimbursement mechanisms, and dynamic ways to adjust price and reimbursement levels in time should be established. Relevant stakeholders should be approached on the potential impacts of DTx through transparent communication and change management strategies should be considered. These findings should be validated with a wider range of stakeholders.

An Innovative Approach to Designing Digital Health Solutions Addressing the Unmet Needs of Obese Patients in Europe.

According to the World Health Organization (WHO), the worldwide obesity rate has tripled since 1975. In Europe, more than half of the population is overweight and obese. Around 2.8 million people die each year worldwide as a result of conditions linked to being overweight or obese. This study aimed to analyze the policies, approaches, and solutions that address the social and health unmet needs of obese patients, at different levels, in order to simulate the definition of an integrated approach, and to provide and share examples of innovative solutions supporting health promotion, disease prevention, and integration of services to improve the collaboration between the different health and care stakeholders involved across the country and in the lives of obese patients. A collaborative approach involving various levels of government and regional experts from different European countries was applied to identify, explore, and evaluate different aspects of the topic, from the innovation perspective and focusing on a European and a regional vision. Currently, people prefer more foods rich in fats, sugars, and salt/sodium than fruits, vegetables, and fiber. This behavior leads to a significant negative impact on their health-related quality of life. Changes in healthcare systems, healthy policy, and approaches to patient care and better implementation of the different prevention strategies between all the stakeholders are needed, taking advantage of the digital transformation of health and care. Such changes can support obese patients in their fight against an unhealthy lifestyle and at the same time reduce healthcare costs.

Digitally Enabled Health Service for the Integrated Management of Hypertension: A Participatory User-Centred Design Process.

This article describes a user-centred approach taken by a group of five procurers to set specifications for the procurement of value-based research and development services for IT-supported integrated hypertension management. The approach considered the unmet needs of patients and health systems of the involved regions. The procurers established a framework for requirements and a solution design consisting of nine building blocks, divided into three domains: service delivery, devices and integration, and health care organisation. The approach included the development of questionnaires, capturing patients' and professionals' views on possible system functionalities, and a template collecting information about the organisation of healthcare, professionals involved and existing IT systems at the procurers' premises. A total of 28 patients diagnosed with hypertension and 26 professionals were interviewed. The interviewees identified 98 functional requirements, grouped in the nine building blocks. A total of nine use cases and their corresponding process models were defined by the procurers' working group. As result, a digitally enabled integrated approach to hypertension has been designed to allow citizens to learn how to prevent the development of hypertension and lead a healthy lifestyle, and to receive comprehensive, individualised treatment in close collaboration with healthcare professionals.

The Costs and Benefits of SNOMED CT Implementation: An Economic Assessment Model.

As part of its investigations, the EU-funded ASSESS CT project developed an Economic Assessment Model for assessing SNOMED CT's and other terminologies' socio-economic impact in a systematic approach. Methodology and key elements of the model are presented: cost and benefit indicators for assessing deployment, and a cost-benefit analysis tool to collect, estimate, and evaluate data.