The online version of this article (doi:10.1186/s12874-017-0324-6) contains supplementary material, which is available to authorized users.
With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature.
The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy.
We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.
Additional file 1: Microsoft Word Document. Secure Host address SSL: Description of the Secure Socket Layer (SSL) used for data connections. (DOCX 16 kb)12874_2017_324_MOESM1_ESM.docx
Chakravorty R. A programmable service architecture for mobile medical care. In: Fourth Annual IEEE International Conference on Pervasive Computing and Communications Workshops (PERCOMW’06): 2006. Pisa: IEEE; 2006. pp. 532–36. doi: 10.1109/PERCOMW.2006.11.
Matthews M, Doherty G, Coyle D, Sharry J. Designing mobile applications to support mental health interventions. Handbook of research on user interface design and evaluation for mobile technology. 2008;635-656.
Avancha S, Baxi A, Kotz D. Privacy in mobile technology for personal healthcare. ACM Computing Surveys (CSUR). 2012;45(1):3. CrossRef
Kotz D, Fu K, Gunter C, Rubin A. Security for mobile and cloud frontiers in healthcare. Commun ACM. 2015;58(8):21–3. CrossRef
Benfield JA, Szlemko WJ. Internet-based data collection: Promises and realities. J Res Pract. 2006;2(2):1.
Cavoukian, A. A Guide to the Personal Health Information Act. Information and Privacy Commissioner of Ontario. December 2004. From https://www.ipc.on.ca/wp-content/uploads/Resources/hguide-e.pdf. Accessed 13 Nov 2015.
Canadian Institutes of Health Research, Natural Science and Engineering Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2010. From http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf. Accessed 13 Nov 2015.
Stopczynski A, Pietri R, Pentland A, Lazer D, Lehmann S. Privacy in sensor-driven human data collection: A guide for practitioners. arXiv preprint arXiv:1403.5299. 2014.
Albrecht U, Von Jan U, Pramann O. Standard reporting for medical apps. Stud Health Technol Inform. 2012;190:201–3.
Peel D. U.S. Public Sharply Divided on Privacy Risks of Electronic Medical Records. From https://patientprivacyrights.org/?p=2577. Accessed 3 Jan 2017.
Grant D, Di Re M. Protecting Health Information in an Electronic Environment. Ontario Privacy Commissioner of Ontario Meeting Reaching Out to Ontario. May 6, 2015. From https://www.ipc.on.ca/wp-content/uploads/2016/09/health-powerpoint-roto-london.pdf. Accessed 3 Jan 2017.
- Implementation of clinical research trials using web-based and mobile devices: challenges and solutions
Stefanie De Jesus
Jamie A. Seabrook
- BioMed Central
Neu im Fachgebiet AINS
Meistgelesene Bücher aus dem Fachgebiet AINS
Mail Icon II