Evidence map›Paper›PMID 35304561›Full record

ArticleNPJ digital medicine2022

Health app policy: international comparison of nine countries' approaches.

Anna Essén, Ariel D Stern, Christoffer Bjerre Haase, Josip Car, Felix Greaves, Dragana Paparova, Steven Vandeput, Rik Wehrens, David W Bates

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ digital medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  8. Overdiagnosis in atrial fibrillation screening with wearables.Scandinavian journal of primary health care · 2026
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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Anna EssénHouse of Innovation, Stockholm School of Economics, Stockholm, Sweden. anna.essen@hhs.se.ORCID http://orcid.org/0000-0003-3566-8409
Ariel D SternHarvard Business School, Harvard University, Boston, MA, USA.ORCID http://orcid.org/0000-0002-3586-1041
Christoffer Bjerre HaaseDepartment of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID http://orcid.org/0000-0003-3895-518X
Josip CarCentre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.ORCID http://orcid.org/0000-0001-8969-371X
Felix GreavesDepartment of Primary Care and Public Health, Imperial College London, London, UK.
Dragana PaparovaDepartment of Information Systems, Centre for e-Health and Centre for Digital Transformation, University of Agder, Kristiansand, Norway.
Steven VandeputbeMedTech VZW, Strombeek-Bever, Belgium.
Rik WehrensSchool of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands.
David W BatesHarvard Medical School and Harvard T. H. Chan School of Public Health, Harvard University, Boston, MA, USA.ORCID http://orcid.org/0000-0001-6268-1540

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of safe and effective apps for health care practitioners and patients to generate the most health benefit as well as guide payer coverage decisions. Nearly all developed countries are attempting to define policy frameworks to improve decision-making, patient care, and health outcomes in this context. This study compares the national policy approaches currently in development/use for health apps in nine countries. We used secondary data, combined with a detailed review of policy and regulatory documents, and interviews with key individuals and experts in the field of digital health policy to collect data about implemented and planned policies and initiatives. We found that most approaches aim for centralized pipelines for health app approvals, although some countries are adding decentralized elements. While the countries studied are taking diverse paths, there is nevertheless broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security. The sheer number of apps on the market in most countries represents a challenge for clinicians and patients. Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety, and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals. Cross-national efforts are needed around regulation and for countries to realize the benefits of these technologies.

Identifiers

PMID35304561
PMCPMC8933556

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.