Table 1.
National approaches to health apps policy (policy process).
| Country | Actors developing national framework | Intended use of framework | Key regulations underpinning framework | National framework for market access approval developed | Reimbursement approval framework developed | End-user interface to clinical practice/ patients |
|---|---|---|---|---|---|---|
| Belgium (BE) | Initiative of the Federal Belgian Government. Three national authorities involved in defining the criteria are: Federal Agency for Medicine and Health Products (FAMHP), The eHealth Platform, NIHDI (National Institute for Health and Disability Insurance) | Centralized procedure run by 2 industry federations, namely beMedTech (medical technologies) and Agoria (representing companies in the technology sector) | EU Medical Device Regulation, Belgian law on data privacy | Yes, mHealthBelgium portal as quality seal listing all apps that fulfil criteria, on different levels (M1-M2-M3) | Yes, mHealthBelgium framework is unique path to submit financing/reimbursement dossier and all nationally financed/reimbursed apps will be listed there in level 3 | Currently not applicable. The mHealthBelgium portal only lists all apps but prescription or activation is not happening via the portal |
| Denmark (DK) | Danish Medicine Agency (https://laegemiddelstyrelsen.dk/en/devices/new-tech-new-technological-possibilities-and-medical-devices (2020, as well as a collaboration of the Danish Health Data Authority, the Government, the interest organization for the five regions in Denmark, Danish Regions, and the interest organization of all the Danish municipalities, Local Government Denmark (Digital Health Strategy https://sundhedsdatastyrelsen.dk/-/media/sds/filer/english/digital_health_solutions/digital_health_strategy_2018_2022.pdf?la=da (2018)) | Expected centralized approach | Danish law (Retsinformation https://www.retsinformation.dk/eli/lta/2008/1263 (2008)), EU regulations (Eur-Lex https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746 (2017)) | Not established yet, work in progress | Not established yet | Not established yet. Planned to be on the Danish e-Health Portal (https://sundhedsdatastyrelsen.dk/-/media/sds/filer/strategi-og-projekter/strategi-digital-sundhed/analyse-af-guide-til-sundhedsapps-04,-d-,01,-d-,19.pdf?la=da (2019)) |
| England (EN) | Medicines and Healthcare Regulatory Agency, National Institute of Health and Care Excellence, NHSX | Centralized approach. Formal regulation of apps is done by the MHRA (medical device regulator). Adoption of technology is supported by NHSX – a national digital transformation agency for health. Health technology evaluation of apps –is done by NICE. Work is underway to bring these various approaches together as a simple and rapid regulation and access pathway. | UK Medicines and Medical Devices Act 2021 and UKCA marking | Yes, the Digital Technology Assessment Criteria (DTAChttps://www.nhsx.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/ (n.d.)). Standards for evidence of effectiveness and cost effectiveness of digital health technologies (provided by NICE https://www.nice.org.uk/about/what-we-do/our-programmes/evidence-standards-framework-for-digital-health-technologies (2021)). A joined up regulatory pathway and reimbursement framework are under development. | Not yet established – in development | https://www.nhs.uk/apps-library/ |
| Germany (G) | Federal Ministry of Health (BMG) in collaboration with the Federal Institute for Drugs and Medical Devices (BfArM). Advising by the Health Innovation Hub (an independent think tank of the BMG, that advised the ministry on digital topics in particular from 2019–2021) | Centralized procedure run by the BfArM | German law (Digital Healthcare Act (DVG) and Digital Health Applications Ordinance (DiGAV)), EU regulations | Yes, implemented in the Fast-Track process run by the BfArM (https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf (2021)); Apps are approved (provisionally or finally/permanently) for clinician prescription and patient use. | Yes, implemented in the Fast-Track process. Approval by the BfArM for listing in the DiGA Directory implies reimbursement approval for all apps that are prescribed to patients in the statutory health insurance system. Manufacturers’ list prices are paid for the first year of marketing after which time reimbursement amounts are governed by price negotiations between manufacturers and the National umbrella organization of statutory health insurers. (This approach mirrors drug reimbursement in the German system.) | Apps available by prescription (and thus reimbursed by the statutory health insurance system) are listed in the DiGA Directory (BfArM https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf (2021)). Users can download these apps from traditional sources such as the App and Play stores, but require an activation code for use. |
| Netherlands (NL) | Ministry of Public Health, Well-being and Sports (VWS), Inspectorate for Health care and Youth (IGJ), The National Institute for Public Health and the Environment (RIVM), The Netherlands Standard Institute (NEN), National eHealth Living Lab (NeLL) | Expected centralized and federated approach. | Dutch law (https://wetten.overheid.nl/BWBR0023864/2019-07-01; https://wetten.overheid.nl/BWBR0040940/2018-05-25), EU regulations | Not established yet. Multiple guides for evaluating health apps developed, (e.g., Medical App Checker by Dutch Medical Association, and evaluation guide by the Dutch Community Health Services. These initiatives may be replaced by a Dutch version of the forthcoming CEN-ISO/TS 82304-2 standard | Not established yet | Not yet established. The Dutch Community Health Services runs an Appstore offering guidance regarding the quality of health app |
| Norway (NO) | Directorate of health, Directorate of eHealth and Norwegian Health Network (NHN) as central actors. Additional actors involved: Norwegian Smart Care Cluster and DNV-G (https://www.helsedirektoratet.no/tema/velferdsteknologi/rapporter-og-utredninger/Tryggere%20helseapper.pdf/_/attachment/inline/e3f6f78d-e56c-4c75-ba64-7bb37be4442c:a350b117c4f5ad0db055588fd58b01615e08c9c4/Tryggere%20helseapper.pdf). | In the short run, centralized, built upon the national citizen portal helsenorge.no and its existing tool catalogue. First step is to publish self-care and self-help health apps in an app library. In the long run, apps as medical devices to be integrated in public health services, also available on prescription as part of a central register on helsenorge.no. | Norwegian regulation (Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), CE marking: General Data Protection Rights, ISO 27001 standard, Norwegian Code of Conduct), EU regulations. | Yes, work in progress as part of the “Safer use of health apps” national framework project. Approved apps will be published in an app library, building upon the existing tool catalogue at helsenorge.no. Apps will be validated with criteria relating to: usability and accessibility, data security, privacy and health benefits. | Not established yet | Limited number of apps available for prescription through helsenorge.no |
| Singapore (SI) | The Ministry of Health Singapore/Health Sciences Authority develops legislations concerning health apps as medical devices. Other stakeholders including industry associations, companies in the medical device industry and members of the public have been consulted (HSA https://www.hsa.gov.sg/docs/default-source/default-document-library/summaryoffeedbackreceivedfromthepublicconsulationontheproposedhealthproductsmedicaldevicesregulations_2aug07.pdf (n.d.)) |
Centralized. Apps must be approved by the HSA prior to releasing the app for use in Singapore. Approval process can range from straight-to-market, expedited review to full review (HSA https://www.hsa.gov.sg/docs/default-source/announcements-csg/press-releases/pr-final_mdlegislationchanges_22may2018.pdf) |
Health Products (Medical Devices) Regulations 2010, Personal Data Protection Act 2012 (PDPA), Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach and the National Telemedicine Guidelines (NTG) (non-legally binding) | Only for apps classified as medical devices. Depending on intended usage, such health apps need to meet standards outlined in the Regulatory Guidelines for Software Medical Devices: A Life Cycle Approach to be approved by HSA for use in Singapore. Alternatively, approval for use can also be fast tracked given a minimum of one out of five reference agencies’ approval (US FDA, European Notified Bodies, the Australian Therapeutic Goods Administration, the Japanese Ministry of Health, Labour and Welfare, and Health Canada), no prior rejection or withdrawal by/from any reference agency or HSA, no safety issues associated with the device globally and three years of marketing history (HSA https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-guidelines-for-telehealth-products-rev-2-1.pdf (2019); https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/regulatory-guidelines-for-software-medical-devices---a-life-cycle-approach.pdf (2020)) | Not established yet |
There is no patient-facing portal compiling all approved apps. A database of registration information is available for public inquiry on the HSA and HealthHub websites (www.healthhub.sg). Health portals associated with the regulatory bodies e.g., HealthHub (https://www.healthhub.sg/Pages/apps.aspx) and Integrated Health Information Systems website (https://www.ihis.com.sg/Project_Showcase/Mobile_Applications (n.d.)) only feature health apps developed by public institutions under Ministry of Health’s supervision. Apps featured are recommended as helpful resources rather than a prescriptive element. There is currently no known effort to curate third-party apps to be recommended to healthcare providers and patients |
| Sweden (SE) | Swedish Institute for Standardization, Medical Products Agency, Health and Social Care Inspectorate, National Board of Health and Welfare, Data Protection Authority, Consumer Agency. The Swedish version of the ISO standard covers both wellness and medical device apps | No path chosen, and there is no obvious actor to use the criteria complementing MDR regulations. Semi-centralized approach where the Swedish Accreditation Agency will certify third party actors who can then approve wellness apps according to criteria discussed | Swedish legislation (Act (1993: 584) on medical devices. 1. Sweden (https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-1993584-om-medicintekniska-produkter_sfs-1993-584); Law with supplementary provisions to the EU regulation on medical devices (SFS 2021: 600) (in Swedish) (https://svenskforfattningssamling.se/sites/default/files/sfs/2021-06/SFS2021-600.pdf?utm_campaign=lv_nyhetsbrev&utm_medium=email&utm_source=newsletter), EU regulations) | Not established yet. Extensive list of national criteria for evaluating quality of both wellness and medical device apps available, based on CEN-ISO/TS 82304-2 standard | Not established yet | Not established yet. One discussed idea is to add quality stamps (symbols) to apps, which may be available via different channels, e.g., Appstores and national health portal (1177.se), according to the emerging ISO standard |
| USA (US) | Food and Drug Administration (FDA) |
Federated. Approval by the FDA for apps embedded in devices or which make normative recommendations (https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program (2021)). The FDA has taken a risk-based approach, and apps that are classified as medical devices and are of moderate or higher risk are subject to FDA regulation. Many wellness apps are not considered to be medical devices. |
Local regulations | No national framework yet. A ‘fast-track’ pathway is in testing | Not established yet | Not established |