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.

ICT for quality and safety of care: beyond interoperability.

Risk Management in healthcare is a particularly challenging task. From a health system perspective a systemic and person centered approach is needed. From an ICT perspective, continuity of care and sharing information for clinical purposes, research and care improvement can be supported though interoperable systems and services and concurrent ability of proper interpretation of this knowledge by different users. Research provides solutions to specific patient safety challenges. Supporting the dynamics of change will furthermore necessitate strategies to shorten the innovation cycle from research to implementation, deployment, adoption and routine use. Transferring research results to deployable solutions requires in addition a high degree of co-ordination at EU level, with strong links to the national competent organisations and stakeholder communities. The breadth and complexity of the issues that need to be addressed require that an appropriate, EU Collaborative Governance is set up.

eHealth in Greece: strategic and implentation perpectives.

The main elements of the Greek Strategy for eHealth are presented, against a background overview of recent, relevant policy development. These elements, together with the current state of implementation were captured by the eHealth ERA survey on progress in individual Member States. An assessment of findings against targets set by the EU eHealth Action Plan and a reflection on the key success factors for converting policy into results are also presented.

Estimation of the heart respiratory motion with applications for cone beam computed tomography imaging: a simulation study.

Computed tomography (CT) reconstruction methods assume imaging of static objects; object movement during projection data acquisition causes tomogram artifacts. The continuously moving heart, therefore, represents a complicated imaging case. The associated problems due to the heart beating can be overcome either by using very short projection acquisition times, during which the heart may be considered static, or by ECG-gated acquisition. In the latter case, however, the acquisition of a large number of projections may not be completed in a single breath hold, thus heart displacement occurs as an additional problem. This problem has been addressed by applying heart motion models in various respiratory motion compensation algorithms. Our paper focuses on cone beam computed tomography (CBCT), performed in conjunction with isocentric, fluoroscopic equipment, and continuous ECG and respiratory monitoring. Such equipment is used primarily for in-theater three-dimensional (3-D) imaging and benefits particularly from the recent developments in flat panel detector technologies. The objectives of this paper are: i) to develop a model for the motion of the heart due to respiration during the respiratory cycle; ii) to apply this model to the tomographic reconstruction algorithm, in order to account for heart movement due to respiration in the reconstruction; and iii) to initially evaluate this method by means of simulation studies. Based on simulation studies, we were able to demonstrate that heart displacement due to respiration can be estimated from the same projection data, required for a CBCT reconstruction. Our paper includes semiautomatic segmentation of the heart on the X-ray projections and reconstruction of a convex 3-D-heart object that performs the same motion as the heart during respiration, and use of this information into the CBCT reconstruction algorithm. The results reveal significant image quality improvements in cardiac image reconstruction.