ArticleJMIR medical informatics2016
A Legal Framework to Support Development and Assessment of Digital Health Services.
Article in JMIR medical informatics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methods to Evaluate the Effects of Internet-Based Digital Health Interventions for Citizens: Systematic Review of Reviews.Journal of medical Internet research · 2018Pooled it
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- Assessing the Quality and Impact of eHealth Tools: Systematic Literature Review and Narrative Synthesis.JMIR human factors · 2023Review
- Opportunities for digital health technology: identifying unmet needs for bipolar misdiagnosis and depression care management.Frontiers in digital health · 2023Article
- Digital Technologies and Data Science as Health Enablers: An Outline of Appealing Promises and Compelling Ethical, Legal, and Social Challenges.Frontiers in medicine · 2021Review
- Barriers and Enablers Affecting Successful Implementation of the Electronic Health Service Sisom: Multicenter Study of Child Participation in Pediatric Care.Journal of medical Internet research · 2019Article
- Sustainable Adoption of Digital Health Innovations: Perspectives From a Stakeholder Workshop.Journal of medical Internet research · 2019Article
- The Biopsychosocial-Digital Approach to Health and Disease: Call for a Paradigm Expansion.Journal of medical Internet research · 2018Article
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Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDigital health services empower people to track, manage, and improve their own health and quality of life while delivering a more personalized and precise health care, at a lower cost and with higher efficiency and availability. Essential for the use of digital health services is that the treatment of any personal data is compatible with the Patient Data Act, Personal Data Act, and other applicable privacy laws.
objectiveThe aim of this study was to develop a framework for legal challenges to support designers in development and assessment of digital health services.
methodsA purposive sampling, together with snowball recruitment, was used to identify stakeholders and information sources for organizing, extending, and prioritizing the different concepts, actors, and regulations in relation to digital health and health-promoting digital systems. The data were collected through structured interviewing and iteration, and 3 different cases were used for face validation of the framework.
resultsA framework for assessing the legal challenges in developing digital health services (Legal Challenges in Digital Health [LCDH] Framework) was created and consists of 6 key questions to be used to evaluate a digital health service according to current legislation.
conclusionsStructured discussion about legal challenges in relation to health-promoting digital services can be enabled by a constructive framework to investigate, assess, and verify the digital service according to current legislation. The LCDH Framework developed in this study proposes such a framework and can be used in prospective evaluation of the relationship of a potential health-promoting digital service with the existing laws and regulations.
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Registered trials
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.