Framework for reimbursement decisions of digital health technologies (mHealth) and its (retrospective) application on selected examples

Research area: HTA-methods & steering instruments

Duration: May 2020 – November 2020
Language: German (with English summary)

Background:

The increasing use of digital technologies [1, 2].  in healthcare creates novel challenges for decision makers to evaluate these applications. Digital health applications have the potential to improve the monitoring and management of diseases. However, for most of the available health apps there is a lack of evidence on their efficacy [3, 4].  In Germany the „Digital Care Act“ (DVG, Digitale-Versorgung-Gesetz) will soon allow doctors the prescription and reimbursement of health apps [5].  Certain health apps can already be reimbursed by some (german, belgian, dutch as well as austrian) health insurances.

The existing frameworks for the assessment of digital health applications often don’t cover all domains of a full HTA. Additionally the thorough evaluation of a digital health application requires domains that are not covered in a conventional HTA report (technology-specific considerations such as software updates, connectivity, compatibility as well as data privacy) [6].

Another consideration is the increasing use of Artificial Intelligence (AI) and robotics in health applications. In March 2019 the british NICE (National Institute for Health and Care Excellence) published an evidence standards framework which may be used with digital health technologies (DHTs) that incorporate AI using fixed algorithms. This framework is however not suitable for DHTs that incorporate AI using adaptive algorithms (self learning algorithms, machine learning, algorithms that continually and automatically change their behaviour) [7].  In November 2019 the University of Oulu (Finland) published the first HTA framework that combines novel technologies like mHealth, AI and robotics, albeit leaving out ethical, social and legal issues [8].

The demand for a standardized assessment tool for transparent evaluation of digital health technologies is high. Not only decision makers, but also technology developers and patients can benefit from a digital health technology assessment tool. Even if digital health applications differ from conventional interventions in healthcare they should fulfill the same level of evidence on effectiveness, potential harm and associated costs.

Project objective and research questions:

The aim of the project is to test the applicability of the currently available frameworks on digital health applications. The following research questions are to be answered:

• Q1: Which international assessment tools for digital health applications (standalone software, mHealth) exist that can be used for reimbursement decisions?
• Q2: Which digital health applications (standalone software, mHealth) are already reimbursed by health insurances of selected countries?
• Q3: What is the evidence on the effectiveness of these digital health applications? Does it match the required evidence standards from the international assessment frameworks?

Methods:

The following methods are used to answer the research questions:

• Q1: Systematic literature search on reviews of assessment tools that can be used for reimbursement decisions on digital health applications and, if applicable, their evaluation.
• Q2: Handsearch for already reimbursed digital health applications (standalone software, mHealth) by „scanning“ digital health application websites as well as health insurance websites of selected countries.
• Q3: Handsearch on the evidence of effectiveness of the digital health applications that were identified in Q2, applying the international assessment tools.

Milestones:

Period	Activity
May-June 2020	Scoping, systematic literature search for Q1, selection of literature
July 2020	Analysis of literature on Q1, Handsearch on Q2 + Q3
August-September 2020	Writing the report, web research on reimbursed applications in selected countries
October 2020	Internal and external review

References:

[1] Oh H, Rizo C, Enkin M, Jadad A, What is eHealth: A systematic Review of Published Definitions, J Med Internet Res 2005;7(1):e1, https://www.jmir.org/2005/1/e1/pdf

[2] World Health Organization (WHO), eHealth at WHO, https://www.who.int/ehealth/about/en/

[3] Lunde P, Blakstad Nilsson B, Bergland A, Jorunn Kværner K, Bye A,   The Effectiveness of Smartphone Apps for Lifestyle Improvement in Noncommunicable Diseases: Systematic Review and Meta-Analyses, J Med Internet Res  2018 May 4;20(5):e162,  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5960039/?report=printable

[4] Wang K,  Varma DS, Prosperi M, A Systematic Review of the Effectiveness of Mobile Apps for Monitoring and Management of Mental Health Symptoms or Disorders, J Psychiatr Res 2018 Dec;107:73-78

[5] Digitale-Versorgung-Gesetz – DVG, https://www.bundesgesundheitsministerium.de/digitale-versorgung-gesetz.html

[6]  Moshi MR, Tooher R,   Merlin T,  Suitability of Current Evaluation Frameworks for Use in the Health Technology Assessment of Mobile Medical Applications: A Systematic Review, Int J Technol Assess Health Care, 2018 Jan;34(5):464-475

[7] National Institute for Health and Care Excellence (NICE), Evidence Standards Framework for Digital Health Technologies, https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies

[8]  Haverinen J, Keränen N, Falkenbach P, Maijala A, Kolehmainen T, Reponen J, Digi-HTA: Health technology assessment framework for digital healthcare services. FinJeHeWo, 2019;11(4), 326-341