Towards an Harmonised Assessment of Digital Health Technologies

Last updated on Nov 2, 2024 7 min read ATS, HTA, Salut Digital, JoAvaluo

Digital Health, defined as “the set of tools and services that utilize information and communication technologies (ICT) to prevent, diagnose, treat, monitor, and manage health problems, as well as track and manage lifestyle habits that impact health” (1), has gained significant relevance in recent years. This growth is attributed to digital health’s unique potential to address major challenges threatening the sustainability, universality, equity, and quality of healthcare systems in various European regions (2). Specifically, digital health technologies (DHTs) hold the potential to enhance the availability, accessibility, acceptability, and efficiency of healthcare services (1,2). Certain authors, including Kickbusch et al. (2021) (3) and Kessel et al. (2024) (4), even propose that DHTs can be seen both as tools with the capacity to influence health determinants and as health determinants in their own right.

However, given the extensive proliferation and availability of DHTs on the market and the limited availability of material (e.g., infrastructure), human, and economic resources within healthcare systems, clearly defined tools, initiatives, and strategies are needed to identify, select, implement, and deploy the most appropriate DHTs based on the needs of society as a whole (2). In this regard, health technology assessment (HTA) stands out as one of the primary tools available to healthcare systems for determining the value of a particular health technology (including DHTs) at different points in its lifecycle (5–7). Nevertheless, assessing DHTs requires specific tools, methodologies, and approaches due to the intrinsic characteristics that define them (e.g., generation, mobilization, and use of large quantities of data, dynamic interaction with users, rapid technological development), which differentiate them from non-digital health technologies (8,9).

In this context, several countries have recently developed and implemented specific methodological frameworks for the evaluation of DHTs to facilitate evidence-based decision-making (e.g., funding, disinvestment, etc.) (10). The countries that currently have such frameworks in place include (10): Germany, Belgium, Spain, Estonia, Finland, France, the Netherlands, and the United Kingdom.

As these instruments were developed within specific contexts, based on specific needs and national perspectives, there are various differences among them. For example, Spain’s methodological framework for the National Health System (NHS) (11), developed by the Agency for Health Quality and Assessment of Catalonia (AQuAS) in collaboration with all agencies comprising the Spanish Network of Agencies for Assessing National Health System Technologies and Performance and other leading health sector professionals, describes 13 domains, 41 dimensions, 9 sub-dimensions, and 21 evidence standards (these latter based on NICE’s Evidence Standards Framework (ESF)). By contrast, Finland’s Digi-HTA framework comprises six evaluation domains, two of which are further divided into several dimensions (12), while the framework in use in the United Kingdom is structured around 21 evidence standards (13).

In this context, and with the aim of harmonizing the assessment of DHTs at the European level, three different initiatives have emerged: the European Taskforce for Harmonised Evaluations of Digital Medical Devices (DMDs) (14); ASSESS DHT (15); and European Digital Health Technology Assessment (EDiHTA) (16).

The European Taskforce for Harmonised Evaluations of Digital Medical Devices (DMDs), or DMD Taskforce, was launched in 2022 with the overarching objective of facilitating the assessment and reimbursement of digital medical devices in a harmonized manner across Europe by creating a common assessment framework (14). The DMD Taskforce is chaired by the Ministerial Digital Health delegation of the French Ministry of Health and Prevention, co-chaired by the European Network for Health Technology Assessment (EUnetHTA), coordinated by EIT Health, and comprises 20 members from various sectors (academic, political, etc.) and EU countries such as Germany, Austria, Belgium, Spain, Finland, France, Italy, and Luxembourg (17).

ASSESS DHT is an EU-funded project with the aim of “consolidating and streamlining existing methods and tools for the approval of innovative DHT and developing a new, fit-for-purpose, generic health technology assessment (HTA) framework for Digital Health Technologies (DHTs)” (15,18). The consortium responsible for this project comprises 14 partners from seven different countries representing a variety of stakeholders (e.g., HTA agencies, DHT developers). Specifically, its members include (18): empirica Communication and Rechnology Research; The European Institute for Innovation Trhought Health Data, Fundación Progreso y Salud de la Consejería de Salud y Consumo de la Junta de Andalucía; Dresden University of Technology; The Austrian Institute for Health Technology Assessment; The Dental and Pharmaceutical Benefits Agency; International Diabetes Federation Europe; The Univeristé libre de Bruxelles; Technische Universität Berlin, Better Care; Tech4Care; University of Oxforc; National Institute for Health and Care Excellence.

Finally, EDiHTA is a four-year EU-funded project that aims to develop the first flexible, inclusive, validated, and ready-for-use European HTA framework capable of assessing various DHTs at Technology Readiness Levels (TRL) 6-7 (16). This framework will allow for the evaluation of different DHTs (e.g., telemedicine, mobile applications, AI) at different TRLs, across territorial levels (national, regional, and local), and from various perspectives (e.g., payers, society, hospitals) (16). The consortium behind this project is coordinated by the Università Cattolica del Sacro Cuore and includes a total of 16 partners from 10 countries, representing various stakeholders involved in DHT assessment. Specifically, it includes (19): Università Cattolica del Sacro Cuore (UCSC); Radboud University Medical Center (RUMC); Odense University Hospital (OUH); Research Foundations Clínic Barcelona – August Pi i Sunyer Biomedical Research Institute (FCRB – IDIPABS); Clinic Barcelona University Hospital (HCB); University Hospital Frankfurt (GUF); The Italian National Agency for Regional Healthcare Services (AGENAS); Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS); Norwegian Centre for E-health Research (NSE); DNV AS (DNV); European Health Management Agency (EHMA); EIT Health e.V. (EITH); European Patients’ Forum (EPF); Health Policy Institute; accelopment Schweiz AG; National institute for Health and Care Excellence (NICE).

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Bibliografia:

  1. European Commission. eHealth: Digital Health and Care - Preparing for the future. 2019.
  2. World Health Organization. Global Strategy on Digital Health. Vol. 57, Indian Pediatrics. 2020. 356-358 p.
  3. Kickbusch I, Piselli D, Agrawal A, Balicer R, Banner O, Adelhardt M, et al. The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world. Lancet. 2021;398(10312):1727-76.
  4. Kessel R Van, Kessel R Van, Seghers L, Anderson M, Nienke M, Monti G, et al. A scoping review and expert consensus on digital determinants of health. :1-48.
  5. Agència de Qualitat i Avaluació Sanitàries de Catalunya. Tecnologies sanitàries [Internet]. 2024 [citat 20 octubre 2024]. Disponible a: https://aquas.gencat.cat/ca/fem/avaluacio/tecnologies-sanitaries/
  6. O’Rourke B, Oortwijn W, Schuller T. The new definition of health technology assessment: A milestone in international collaboration. Value Heal. 2020;23(6):824-5.
  7. Secretaria General de Salud Digital I e I para el S. Estrategia de salud digital. Sistema nacional de salud. Minist Sanidad Gob España. 2021;
  8. Gomes M, Murray E, Raftery J. Economic Evaluation of Digital Health Interventions: Methodological Issues and Recommendations for Practice. Pharmacoeconomics. 2022;40(4):367-78.
  9. Benedetto V, Filipe L, Harris C, Spencer J, Hickson C, Clegg A. Analytical Frameworks and Outcome Measures in Economic Evaluations of Digital Health Interventions: A Methodological Systematic Review. Med Decis Mak. 2023;43(1):125-38.
  10. Tarricone R, Petracca F, Weller HM. “Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning”. npj Digit Med. 2024;7(1):1-12. 

  11. Segur-Ferrer J, Moltó-Puigmartí C, Pastells-Peiró R, Estrada Sabadell MD, Vivanco-Hidalgo RM. Marco de evaluación de tecnologías sanitarias: adaptación para la evaluación de tecnologías de salud digital: guía de usuario. [Nombre Complet la Rev o Ser. 2023;[Volumen]([Número de edición]):[Páginas]. 

  12. Haverinen J, Turpeinen M, Falkenbach P, Reponen J. Implementation of a new Digi-HTA process for digital health technologies in Finland. Int J Technol Assess Health Care. 2022;38(1). 

  13. NICE. Evidence standards framework for digital health technologies. Natl Inst Heal Care Excell. 2022;(April):1-34. 

  14. EIT Health. European Taskforce for Harmonised Evaluations of Digital Medical Devices (DMDs). 2022.

  15. ASSESS DHT. About the project [Internet]. 2024 [citat 2 novembre 2024]. Disponible a: https://assess-dht.eu/the-project/

  16. EDiHTA. About EDiHTA [Internet]. 2024 [citat 2 novembre 2024]. Disponible a: https://edihta-project.eu/about/

  17. EIT Health. DMD Taskforce members [Internet]. 2022 [citat 2 novembre 2024]. Disponible a: https://eithealth.eu/dmd-taskforce-members/

  18. ASSESS DHT. Consortium. 2024. 

  19. EDiHTA. Partners [Internet]. 2024 [citat 2 novembre 2024]. Disponible a: https://edihta-project.eu/partners/
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