Journal:A legal framework to support development and assessment of digital health services

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Full article title A legal framework to support development and assessment of digital health services
Journal JMIR Medical Informatics
Author(s) Garrell, Cecilia; Svedberg, Petra; Nygren, Jens M.
Author affiliation(s) School of Health and Welfare at Halmstad University
Primary contact Email: jens.nygren [at] hh.se; Phone: 46 35167863
Editors Eysenbach, G.
Year published 2016
Volume and issue 4 (2)
Page(s) e17
DOI 10.2196/medinform.5401
ISSN 2291-9694
Distribution license Creative Commons Attribution 2.0
Website http://medinform.jmir.org/2016/2/e17/
Download http://medinform.jmir.org/2016/2/e17/pdf (PDF)
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Abstract

Background: Digital 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.

Objective: The aim of this study was to develop a framework for legal challenges to support designers in development and assessment of digital health services.

Methods: A 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 three different cases were used for face validation of the framework.

Results: A framework for assessing the legal challenges in developing digital health services (Legal Challenges in Digital Health [LCDH] Framework) was created and consists of six key questions to be used to evaluate a digital health service according to current legislation.

Conclusions: Structured 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

Keywords: digital health; legal aspects; technological innovations

Introduction

Through the use of wireless devices, sensor technologies, the Internet, social networks, health information technology (IT), and personal health data, digital health services empower people to track, manage, and improve their own health and quality of life. At the same time, these services provide a more personalized and precise health care delivery, at a lower cost and with higher efficiency and availability.[1] An emerging area at the intersection of informatics, health care, and business is electronic health (eHealth)[2], which encompasses the mediation and interaction between health care and the individual via information and communication technology (ICT).[3] Although the extent of implementation and application of eHealth systems vary, the overall goal is the same: using ICT to provide better care more efficiently at a lower cost.[4] Mobile health (mHealth), as a component of eHealth, involves the use and capitalization on mobile devices[5] and encompasses any use of mobile technology to address health care challenges such as access, quality, affordability, matching of resources, and behavioral norms.[6] The use of mHealth offers great opportunities by allowing asynchronous and remote care[7] to an extensive number of potential users.[5] Applications for mHealth serve a variety of functions: providing easy access to medical information about the symptoms and treatment of various diseases or allowing patients to track clinical measurements that can be sent to the care provider.[6] These applications could change the nature of health care[8] by using technology to increase patient engagement, improve care quality, transform care processes[6], reduce health care costs, and minimize human error.[9]

References

  1. ↑ Topol, E.J. (2012). The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books. pp. 320. ISBN 9780465025503. 
  2. ↑ Eysenbach, G. (2001). "What is e-health?". Journal of Medical Internet Research 3 (2): e20. doi:10.2196/jmir.3.2.e20. PMC PMC1761894. PMID 11720962. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761894. 
  3. ↑ "eHealth". European Commission. http://ec.europa.eu/health/ehealth/policy/index_en.htm. Retrieved 27 April 2016. 
  4. ↑ Editor Connect (6 June 2012). "High tech for health". European Commission. https://ec.europa.eu/digital-single-market/en/news/high-tech-health. Retrieved 27 April 2016. 
  5. ↑ 5.0 5.1 WHO Global Observatory for eHealth (2011). "mHealth: New horizons for health through mobile technologies: Second global survey on eHealth". World Health Organization. pp. 102. http://apps.who.int/iris/handle/10665/44607. 
  6. ↑ 6.0 6.1 6.2 Schulke, D.F. (2013). "The regulatory arms race: Mobile health applications and agency posturing". Boston University Law Review 93: 1699–1752. 
  7. ↑ Kramer, G.M.; Kinn, J.T.; Mishkind, M.C. (2015). "Legal, Regulatory, and Risk Management Issues in the Use of Technology to Deliver Mental Health Care". Cognitive and Behavioral Practice 22 (3): 258–268. doi:10.1016/j.cbpra.2014.04.008. 
  8. ↑ Ferguson, B. (2012). "The Emergence of Games for Health". Games for Health Journal 1 (1): 1–2. doi:10.1089/g4h.2012.1010. PMID 26196423. 
  9. ↑ Fellay, S. (4 August 2014). "Changing the rules of health care: Mobile health and challenges for regulation". American Enterprise Institute. 

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. In several cases the PubMed ID was missing and was added to make the reference more useful.

Per the distribution agreement, the following copyright information is also being added:

©Cecilia Garell, Petra Svedberg, Jens M Nygren. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 25.05.2016.

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