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Development of a health technology assessment module for evaluating mobile medical applications

Published online by Cambridge University Press:  18 May 2020

Magdalena Ruth Moshi Open the ORCID record for Magdalena Ruth Moshi [Opens in a new window] ,
Rebecca Tooher  and
Tracy Merlin
Magdalena Ruth Moshi*
Affiliation:
School of Public Health, University of Adelaide, Adelaide, Australia
Rebecca Tooher
Affiliation:
Division of Academic Student and Engagement, University of Adelaide, Adelaide, Australia
Tracy Merlin
Affiliation:
Adelaide Health Technology Assessment (AHTA), School of Public Health, University of Adelaide, Adelaide, Australia
*
Author for correspondence: Magdalena Ruth Moshi, E-mail: magdalena.moshi@adelaide.edu.au
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Abstract

Objective

The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes.

Methods

In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs.

Results

Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians.

Conclusion

An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.

Keywords

Technology assessmentHealth policy/standardsMobile healthMobile applications
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 36 , Issue 3 , June 2020 , pp. 252 - 261
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

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References

World Health Organization. Telemedicine: opportunities and developements in memeber states: report on the second global survey on eHealth. Gobal Observatory for eHelath series. Geneva; 2009.Google Scholar
World Health Organization. mHealth: new horizons for health through moblie technologies: second global survey on eHealth. Gobal Observatory for eHealth series. Geneva; 2011.Google Scholar
World Health Organization [Internet]. E-Health; 2016. Available from: http://www.who.int/trade/glossary/story021/en/Google Scholar
Byambasuren, O, Sanders, S, Beller, E, Glasziou, P. Prescribable mHealth apps identified from an overview of systematic reviews. NPJ Digit Med. 2018;1(1):12.CrossRefGoogle ScholarPubMed
Therapeutic Goods Administration. Australian Regulatory guidelines for medical devices (ARGMD). Canberra, Australia: Commonwealth of Australia; 2011. pp. 17–33, 74–104, 217–18.Google Scholar
Therapeutic Goods Administration [Internet]. Regulation of medical software and mobile medical 'apps'; 2013. Available from: https://www.tga.gov.au/regulation-medical-software-and-mobile-medical-appsGoogle Scholar
Laranjo, L, Lau, A, Oldenburg, B, Gabarron, E, O'Neill, A, Chan, S et al. mHealth technologies for chronic disease prevention and management: and evidence check review brokered by the Sax Institute for Healthdirect Australia Sax Institute Sax Institute; 2015.Google Scholar
Moshi, MR, Tooher, R, Merlin, T. Suitability of current evaluation frameworks for Use in the health technology assessment of mobile medical applications: A systematic review. Int J Technol Assess Health Care. 2018;34:464–75.CrossRefGoogle ScholarPubMed
U.S. Food and Drug Administration [Internet]. Software as a Medical Device (SaMD); 2017. Available from: https://www.fda.gov/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/default.htmGoogle Scholar
International Medical Device Regulators Forum. “Software as a medical device”:possible framework for risk categorization and corresponding considerations. International Medical Device Regulators Forum; 2014.Google Scholar
International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Clinical Evaluation. International Medical Device Regulators Forum; 2017.Google Scholar
U.S. Department of Health and Human Services Food and Drug Administration. Mobile Medical Applications Guidance for Industry and Food and Drug Adminitration Staff: U.S. Department of Health and Human Services Food and Drug Administration; 2015.Google Scholar
Medical Services Advisory Committee [Internet]. What is the MBS and Medicare? 2016. Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/content/factsheet-03Google Scholar
Medical Services Advisory Committee [Internet]. Australian Government HTA Processes; 2016. Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/factsheet-02Google Scholar
Department of Human Services [Internet]. MBS and telehealth; 2017. Available from: https://www.humanservices.gov.au/organisations/health-professionals/services/medicare/mbs-and-telehealthGoogle Scholar
Australian Digital Health Agency [Internet]. What is My Health Record? 2018. Available from: https://www.myhealthrecord.gov.au/for-you-your-family/what-is-my-health-recordGoogle Scholar
Australian Government [Internet]. My Health Records Act 2012; 2018. Available from: https://www.legislation.gov.au/Details/C2017C00313Google Scholar
Moshi, MR, Parsons, J, Tooher, R, Merlin, T. Evaluation of mobile health applications: Is regulatory policy up to the challenge? Int J Technol Assess Health Care. 2019;35:351–60.CrossRefGoogle ScholarPubMed
Malterud, K, Siersma, VD, Guassora, AD. Sample size in qualitative interview studies: Guided by information power. Qual Health Res. 2016;26:1753–60.CrossRefGoogle ScholarPubMed
Morse, JM. Data were saturated . Qual Health Res. 2015;25:587–88.CrossRefGoogle ScholarPubMed
Morse, JM. All data are not equal. Qual Health Res. 2015;25:1169–70.CrossRefGoogle ScholarPubMed
Braun, V, Clarke, V. Using thematic analysis in psychology. Qual Res. 2006;3:77–101.Google Scholar
QSR International Pty Ltd [Internet]. NVivo 11 for windows; 2018. Available from: http://www.qsrinternational.com/nvivo/nvivo-products/nvivo-11-for-windowsGoogle Scholar
Carter, N, Bryant-Lukosius, D, DiCenso, A, Blythe, J, Neville, AJ. The use of triangulation in qualitative research. Oncol Nurs Forum. 2014;41:545–47.CrossRefGoogle ScholarPubMed
Liamputtong, P. Qualitative research methods. Melbourne: Oxford university press; 2013.Google Scholar
Rossmman, GB, Rallis, SF. An introduction to qualitative research: Learning in the field. London: Sage publications; 2016.Google Scholar
Medical Services Advisory Committee. Technical Guidelines for preparing assessment reports for the Medical Services Advisory Committee – Medical Service Type: Therapeutic Australian Government; 2016.Google Scholar
Forbrukerradet. Consumer protection in fitness wearables. Norway: Forbrukerradet; 2016.Google Scholar
Busse, R, Orvain, J, Velasco, M, Drummond, M, Gurtner, F, Jorgensen, T et al. Best practice in undertaking and reporting health technology assessments – working group 4 report. Int J Technol Assess Health Care. 2002;18:361–422.CrossRefGoogle Scholar
EUnetHTA Joint Action 2 W.P. HTA Core Model version 3.0 EUnetHTA; 2016.Google Scholar
Department of Health [Internet]. Health Technology Assessment (HTA) overview; 2019. Available from: https://www1.health.gov.au/internet/hta/publishing.nsf/Content/commonwealth-1Google Scholar
Duggal, R, Brindle, I, Bagenal, J. Digital healthcare: Regulating the revolution We need an agile and future proof framework that everyone can trust. Br Med J. 2018;360:k6.CrossRefGoogle Scholar
IP Australia [Internet]. IP explained; 2018. Available from: https://www.ipaustralia.gov.au/understanding-ip/getting-started-ip/ip-explainedGoogle Scholar
Australian Health Practitioner Regulation Agency [Internet]. Who we are; 2018. Available from: https://www.ahpra.gov.au/About-AHPRA/Who-We-Are.aspxGoogle Scholar
Therapeutic Goods Administration [Internet]. Regulation basics; 2019. Available from: https://www.tga.gov.au/regulation-basicsGoogle Scholar
Department of Health [Internet]. HTA for reimbursement; 2017. Available from: http://www.health.gov.au/internet/hta/publishing.nsf/Content/reimbursement-1Google Scholar
U.S. Food and Drug Administration. Developing a software precertification program: a working model. U.S. Department of Health and Human Services; 2018.Google Scholar
U.S. Food and Drug Administration [Internet]. Digital health software precertification (Pre-Cert) program; 2017. Available from: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htmGoogle Scholar
U.S. Food and Drug Administration [Internet]. Digital health; 2017. Available from: https://www.fda.gov/MedicalDevices/DigitalHealth/default.htmGoogle Scholar
Shuren, J, Patel, B, Gottlieb, S. FDA Regulation of mobile medical apps. JAMA. 2018;4(320):337–38.CrossRefGoogle Scholar
Boyce, C., Neale, P. Conducting in-depth interviews: A guide for designing and conducting in-depth interviews for evaluation input; 2006.Google Scholar
Rosenbaum, JE, Johnson, BK, Deane, AE. Health literacy and digital media use: Assessing the health literacy skills instrument – short form and its correlates among African American college students. Dig Health. 2018;4:1–8.Google ScholarPubMed
Feilzer, MY. Doing mixed methods research pragmatically: Implications for the rediscovery of pragmatism as a research paradigm. J Mix Methods Res. 2010;4:6–16.CrossRefGoogle Scholar
Morgan, DL. Paradigms lost and pragmatism regained methodological implications of combining qualitative and quantitative methods. J Mix Methods Res. 2007;1(1):48–76.CrossRefGoogle Scholar
Scott, PJ, Briggs, JS. A pragmatist argument for mixed methodology in medical informatics. J Mix Methods Res. 2009;3:223–41.CrossRefGoogle Scholar
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