Digi-HTA: Health technology assessment framework for digital healthcare services

Authors

• Jari Haverinen University of Oulu
• Niina Keränen FinnTelemedicum, Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Finland; Medical Research Center Oulu, Oulu University Hospital and University of Oulu, University of Oulu, Oulu, Finland
• Petra Falkenbach Finnish Coordinating Center for Health Technology Assessment, Oulu, Finland; Oulu University Hospital, Oulu, Finland
• Anna Maijala FinnTelemedicum, Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Finland
• Timo Kolehmainen Centre for Health and Technology, Faculty of Medicine, University of Oulu, Finland
• Jarmo Reponen FinnTelemedicum, Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Finland; Medical Research Center Oulu, Oulu University Hospital and University of Oulu, University of Oulu, Oulu, Finland

DOI:

https://doi.org/10.23996/fjhw.82538

Keywords:

health technology assessment, artificial intelligence, robotics, mHealth

Abstract

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified.

The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare.

In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.

References

Panteli D, Busse R. Health technology assessment at age 25 - Squaring the circle of strong methodology and context-dependency. Health Policy. 2019 Feb;123(2):115-17. https://doi.org/10.1016/j.healthpol.2019.01.007.

WHO. HTA Health technology assessment. World Health Organization; 2019 [Cited 2019 May 5]. Available from: https://www.who.int/health-technology-assessment/en/.

WHO. Health Technology. What is health technology? World Health Organization; 2019 [Cited 2019 May 5]. Available from: https://www.who.int/health-technology-assessment/about/healthtechnology/en/.

Mäkelä M, Kaila M, Lampe K, Teikari M. Menetelmien arviointi terveydenhuollossa. Helsinki: Duodecim; 2007. 206 p.

EUnetHTA. European Network for Health Technology Assessment. Common questions. What is health technology assessment (HTA)? EUnetHTA; 2018 [Cited 2019 May 5]. Available from: https://eunethta.eu/services/submission-guidelines/submissions-faq/.

Gyldmark M, Lampe K, Ruof J, Pöhlmann J, Hebborn A, Kristensen FB. Is the EUnethta hta core model® fit for purpose? Evaluation from an industry perspective. Int J Technol Assess Health Care. 2018 Jan;34(5):458-463. doi: 10.1017/S0266462318000594.

WHO. HTA Informing decision makers. World Health Organization; 2019 [Cited 2019 May 5]. Available from: https://www.who.int/health-technology-assessment/about/en/.

Henshall C, Schuller T. Health technology assessment, value-based decision making, and innovation. Int J Technol Assess Health Care. 2013 Oct;29(4):353-9. doi: 10.1017/S0266462313000378.

DNISH Centre for Evaluation and Health Technology Assessment (DACEHTA). Introduction to Mini-HTA – a management and decision support tool for the hospital service 2005. Danish National Board of Health; 2005 [Cited 2019 May 5]. Available from: http://www.sst.dk/~/media/47C62A769EBC4E80A153F986C5348F55.ashx.

Reponen J, Marttila E, Paajanen H, Turula A. Ex-tending a multimedia medical record to a regional service with electronic referral and discharge letters. J Telemed Telecare. 2004;10 Suppl 1:81-3. https://doi.org/10.1258/1357633042614276.

Harno K, Ruotsalainen P. Sharable EHR systems in Finland. Stud Health Technol Inform. 2006;121:364-70.

European Commission. eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century. Euro-pean Commission; 2012 [Cited 2019 May 12]. Available from: https://ec.europa.eu/health/sites/health/files/ehealth/docs/com_2012_736_en.pdf.

World Health Organization. eHealth. World Health Organization; 2019 [Cited 2019 May 12]. Available from: https://www.who.int/ehealth/en/.

Harno K. UUMA. Regional eHealth services in the hospital district of Helsinki and Uusimaa (HUS). Stud Health Technol Inform. 2004;100:101-8.

Reponen J, Winblad I, Hämäläinen P. Current status of national eHealth and telemedicine development in Finland. Stud Health Technol Inform. 2008;134:199-208.

Ministry of Social Affairs and Health. Information to support well-being and service renewal. eHealth and eSocial Strategy 2020. Ministry of Social Affairs and Health; 2015 [Cited 2019 May 13]. Available from: http://urn.fi/URN:ISBN:978-952-00-3575-4.

The Virtual Hospital 2.0 (Virtuaalisairaala 2.0). Transforming the care experience. The Virtual Hospital 2.0 (Virtuaalisairaala 2.0); 2019 [Cited 2019 May 12]. Available from: http://www.virtuaalisairaala2.fi/en/home.

City of Helsinki. ODA – Self-Treatment Services. City of Helsinki; 2016 [Cited 2019 May 13]. Available from: https://www.hel.fi/sote/en/presentation/Social+and+health+care+services+to+be+reformed/ODA+Self-Treatment+Services/.

Omaolo. Omaolo. SoteDigi Oy; 2019 [Cited 2019 May 22]. Available from: https://www.omaolo.fi/.

Kanta Services. My Kanta Pages PHR. Kanta Ser-vices, The Social Insurance Institution of Finland; 2018 [Cited 2019 Jun 14]. Available from: https://www.kanta.fi/en/system-developers/my-kanta-pages-phr.

Reponen J, Ilkko E, Jyrkinen L, Tervonen O, Niinimäki J, Karhula V, et al. Initial experience with a wireless personal digital assistant as a teleradiology terminal for reporting emergency computerized tomography scans. J Telemed Telecare. 2000;6(1):45-9. https://doi.org/10.1258/1357633001933943.

Istepanian R, Lacal J. Emerging mobile communication technologies for health: some imperative notes on m-health. In: Proceedings of the 25th Annual Interna-tional Conference of the IEEE Engineering in Medicine and Biology Society 2003 Sep 17-21; Cancun, Mexico (IEEE Cat. No.03CH37439). IEEE; 2004 Apr 5. p. 1414-1416. https://doi.org/10.1109/IEMBS.2003.1279581.

Istepanian R, Al-Anzi T. m-Health 2.0: New perspectives on mobile health, machine learning and big data analytics. Methods. 2018 Dec 1;151:34-40. doi: 10.1016/j.ymeth.2018.05.015.

Tiulpin A, Thevenot J, Rahtu E, Lehenkari P, Saarakkala S. Automatic Knee Osteoarthritis Diagnosis from Plain Radiographs: A Deep Learning-Based Approach. Sci Rep. 2018 Jan 29;8(1):1727. doi: 10.1038/s41598-018-20132-7.

AlvinOne. AboutAlvinOne. AlvinOne; 2019 [Cited 2019 May 19]. Available from: http://www.alvinone.com/en/about-alvinone-lang-en/.

Reponen J, Kangas M, Hämäläinen P, Keränen N, Haverinen J. Tieto- ja viestintäteknologian käyttö terveydenhuollossa vuonna 2017. Tilanne ja kehityksen suunta [Use of information and communications technology in Finnish health care in 2017. Current situation and trends, in Finnish]. Report 5/2018. Helsinki: National Institute for Health and Welfare (THL); 2018. Available from: http://urn.fi/URN:ISBN:978-952-343-108-9.

Raghupathi W, Raghupathi V. Big data analytics in healthcare: promise and potential. Health Inf Sci Syst. 2014 Feb 7;2:3. doi: 10.1186/2047-2501-2-3.

Martynov P, Mitropolskii N, Kukkola K, Gretsch M, Koivisto V, Lindgren I, et al. Testing of the assisting software for radiologists analysing head CT images: lessons learned. BMC Med Imaging. 2017 Dec 11;17(1):59. doi: 10.1186/s12880-017-0229-1.

Hennala l, Koistinen P, Kyrki V, Kämäräinen J, Laitinen A, Lanne M, et al. Robotics in Care Services: A Finnish Roadmap. ROSE consortium; 2017 [Cited 2019 May 13]. Available from: http://roseproject.aalto.fi/images/publications/Roadmap-final02062017.pdf.

Ministry of Social Affairs and Health. The Wellbeing and Health Sector’s Artificial Intelligence and Robotics Programme (Hyteairo). Ministry of Social Affairs and Health; 2019 [Cited 2019 May 12]. Available from: https://stm.fi/en/the-well-being-and-health-sector-s-artificial-intelligence-and-robotics-programme-hyteairo-.

Ventä O, Honkatukia J, Häkkinen K, Kettunen O, Niemelä M, Airaksinen M, et al. The effects of robotization and automatization on the Finnish economy 2030 [English abstract]. Prime Minister´s Office; 2018 [Cited 2019 May 13]. Available from: http://julkaisut.valtioneuvosto.fi/bitstream/handle/10024/161102/47-2018-ROBOFINN_raportti_.pdf.

Holopainen A. Mobiiliteknologia ja terveyssovelluk-set, mitä ne ovat? Lääketieteellinen Aikakauskirja Duodecim. 2015;131(13):1285-90.

Buddy Healthcare. Buddy Healthcare; Our Customers and Testimonials. Buddy Healthcare Ltd Oy; 2019 [Cited 2019 May 19]. Available from: http://www.buddyhealthcare.com/customers-and-testimonials.

Gagnon MP, Ghandour EK, Talla PK, Simonyan D, Godin G, Labrecque M, et al. Electronic health record acceptance by physicians: Testing an integrated theoretical model. J Biomed Inform. 2014 Apr;48:17-27. doi: 10.1016/j.jbi.2013.10.010.

Hautamäki E, Kinnunen U, Palojoki S. Health information systems´ usability-related use errors in patient safety incidents. FinJeHeW 2017;9(1):6-17. https://doi.org/10.23996/fjhw.60763

Martínez-Pérez B, De la Torre-Díez I, López-Coronado M. Privacy and security in mobile health apps: a review and recommendations. J Med Syst. 2015 Jan;39(1):181. doi: 10.1007/s10916-014-0181-3.

Morera E, De la Torre Díez I, Garcia-Zapirain B, López-Coronado M, Arambarri J. Security Recommendations for mHealth Apps: Elaboration of a Developer’s Guide. J Med Syst. 2016 Jun;40(6):152. doi: 10.1007/s10916-016-0513-6.

Gruchmann T, Borgert A. The Effect of New Standards on the Global Movement Toward Usable Medical Devices. HCI and Usability for Medicine and Health Care: Third Symposium of the Workgroup Human-Computer Interaction and Usability Engineering of the Austrian Computer Society, USAB 2007 Lecture Notes in Computer Science (LNCS 4799). Berlin, Heidelberg, New York: Springer; 2007. p. 83-96. https://doi.org/10.1007/978-3-540-76805-0_6.

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 Jan;34(5):464-475. doi: 10.1017/S026646231800051X.

Vukovic V, Favaretti C, Ricciardi W, de Waure C. Health technology assessment evidence on e-health/m-health technologies: evaluating the transparency and thoroughness. Int J Technol Assess Health Care. 2018 Jan;34(1):87-96. doi: 10.1017/S0266462317004512.

Ridley C, Tomlinson P, Marsh W. Health Technology Assessment of mHealth Applications: Slow Progress in a Fast-Paced Industry? Value Health. 2018;21(Suppl 3):S272. https://doi.org/10.1016/j.jval.2018.09.1616.

Bradway M, Carrion C, Vallespin B, Saadatfard O, Puigdomènech E, Espallargues M, et al. mHealth As-sessment: Conceptualization of a Global Framework. JMIR Mhealth Uhealth. 2017 May 2;5(5):e60. doi: 10.2196/mhealth.7291.

Zelmer J, van Hoof K, Notarianni M, van Mierlo T, Schellenberg M, Tannenbaum C. An Assessment Framework for e-Mental Health Apps in Canada: Results of a Modified Delphi Process. JMIR Mhealth Uhealth. 2018 Jul 9;6(7):e10016. doi: 10.2196/10016.

NHS. NHS Apps Library. NHS; 2019 [Cited 2019 May 13]. Available from: https://www.nhs.uk/apps-library/.

Postelnicu L. More than 100 digital health and care tools evaluated against key standards for NHS Apps Library. MobiHealthNews; 2018 Nov 14 [Cited 2019 May 13]. Available from: https://www.mobihealthnews.com/content/more-100-digital-health-and-care-tools-evaluated-against-key-standards-nhs-apps-library.

NHS Digital. Digital Assessment Questions V2.2. NHS Digital; 2019 May 19 [Cited 2019 Aug 7]. Available from: https://mhealth.service.nhs.uk/docs/DAQ%202.2.pdf.

Our Mobile Health. Rigorous App Assessment and Review Process. Our Mobile Health; 2017 [Cited 2019 May 13]. Available from: https://www.ourmobilehealth.com/our-process.html.

ORCHA. The ORCHA Review process is the most advanced review mechanism for health and care Apps available anywhere. ORCHA; 2018 [Cited 2019 May 13]. Available from: https://www.orcha.co.uk/our-solution/the-orcha-review/.

ORCHA. App Categories. ORCHA; 2018 [Cited 2019 May 13]. Available from: https://www.orcha.co.uk/about-us/app-categories/.

US Food and Drug Administration. Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration; 2015 Feb [Cited 2019 May 13]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/mobile-medical-applications.

Frosini F, Miniati R, Grillone S, Dori F, Gentili GB, Belardinelli A. Integrated HTA-FMEA/FMECA methodol-ogy for the evaluation of robotic system in urology and general surgery. Technol Health Care. 2016 Nov 14;24(6):873-887. https://doi.org/10.3233/THC-161236.

Barbaro S, Paudice A, Scipioni S, Martin B, Charrier L, Bert F, et al. Robot-assisted radical prostatectomy: A minihealth technology assessment in a teaching hospital. Healthmed. 2012;6(3):724-730.

Wang M, Xie X, Wells D, Higgins C. Robotic Surgical System for Radical Prostatectomy: A Health Technology Assessment. Ont Health Technol Assess Ser. 2017 Jul 7;17(11):1-172.

Reza M, Maeso S, Blasco JA, Andradas E. Meta-analysis of observational studies on the safety and ef-fectiveness of robotic gynaecological surgery. Br J Surg. 2010 Dec;97(12):1772-83. doi: 10.1002/bjs.7269.

Fosch Villaronga E, Roig A. European regulatory framework for person carrier robots. Comput Law Secur Rev 2017 Aug;33(4):502-520. https://doi.org/10.1016/j.clsr.2017.03.018.

Fosch-Villaronga E, Özcan B. The Progressive Inter-twinement Between Design, Human Needs and the Regulation of Care Technology: The Case of Lower-Limb Exoskeletons. Int J Soc Robot. 2019 Mar 9;1-14. https://doi.org/10.1007/s12369-019-00537-8.

Palmerini E, Bertolini A, Battaglia F, Koops BJ, Carnevale A, Salvini P. RoboLaw: Towards a European framework for robotics regulation. Robot Auton Syst. 2016 Dec;86:78-85. https://doi.org/10.1016/j.robot.2016.08.026.

Fosch-Villaronga E. Iterative Learning Governance Process for robot technology. Opening seminar for Hyteairo program 20.11.2018. 2018. [Cited 2019 May 13]. Available from: https://www.slideshare.net/airoisland/hyteairo-kickoff-201128-dr-eduard-fosch-villaronga-iterative-learning-governance-process-presentation.

Love-Koh J, Peel A, Rejon-Parrilla J, Ennis K, Lovett R, Manca A, et al. The Future of Precision Medicine: Potential Impacts for Health Technology Assessment. Pharmacoeconomics. 2018 Dec;36(12):1439-1451. doi: 10.1007/s40273-018-0686-6.

Hossain MS, Muhammad G. Healthcare Big Data Voice Pathology Assessment Framework. IEEE Access. 2016 Nov 8;4:7806-7815. https://doi.org/10.1109/ACCESS.2016.2626316.

High-Level Expert Group on Artificial Intelligence. Ethics Guidelines for Trustworthy AI. European Com-mission; 2019 [Cited 2019 May 13]. Available from: https://ec.europa.eu/futurium/en/ai-alliance-consultation.

Benrimoh D, Israel S, Perlman K, Fratila R, Krause M. Meticulous Transparency - An Evaluation Process for an Agile AI Regulatory Scheme. In: Proceedings of 31st International Conference on Industrial Engineering and Other Applications of Applied Intelligent Systems, IEA/AIE; 2018 June 25–28. Montreal, QC, Canada: Springer International Publishing; 2018. p. 869-880.

Foster KR, Koprowski R, Skufca JD. Machine learning, medical diagnosis, and biomedical engineering research - commentary. Biomed Eng Online. 2014 Jul 5;13:94. doi: 10.1186/1475-925X-13-94.

Consultative Committee of the Convention for the Protection of Individuals with regard to the Processing of Personal Data (Convention, 108). Guidelines on Artificial Intelligence and Data Protection. Council of Europe; 2019 Jan 25 [Cited 2019 May 15]. Available from: https://rm.coe.int/guidelines-on-artificial-intelligence-and-data-protection/168091f9d8.

Aukia JP. Kyberterveys-hankkeella kehitetään sairaaloiden ja koko SOTE-sektorin kyberturvallisuutta. The National Emergency Supply Agency; 2018 Jun 4 [Cited 2019 May 20]. Available from: https://www.varmuudenvuoksi.fi/aihe/huoltovarmuus/375/kyberturvallisuuden_tahden.

Ahonen P. TITAN-käsikirja. VTT Technical Research Centre of Finland; 2010 [Cited 2019 May 20]. Available from: https://www.vtt.fi/inf/pdf/tiedotteet/2010/t2545.pdf.

International Organization for Standardization. ISO 13482:2014 Robots and robotic devices -- Safety requirements for personal care robots. International Organization for Standardization; 2014 [Cited 2019 May 13]. Available from: https://www.iso.org/standard/53820.html.

Luo RC, Shih W. Topological Map Generation for Intrinsic Visual Navigation of an Intelligent Service Robot. In: Proceedings of the 2019 IEEE International Con-ference on Consumer Electronics (ICCE); 2019 Jan 11-13. Las Vegas, NV, USA: IEEE; 2019 Mar 7. p. 1-6. https://doi.org/10.1109/ICCE.2019.8662062.

Ravankar A, Ravankar AA, Kobayashi Y, Jixin L, Emaru T, Hoshino Y. An Intelligent Docking Station Manager for Multiple Mobile Service Robots. 15th International Conference on Control, Automation and Systems (ICCAS 2015); 2015 Oct 13-16, Busan, Korea: IEEE; 2015. https://doi.org/10.1109/ICCAS.2015.7364881.

European Commission. Regulatory framework. European Commission; 2019 [Cited 2019 June 25]. Available from: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en.

The European Parliament and the Council of the European Union. Regulation (EU) 2017/745 of the Eu-ropean Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union; 2017 [Cited 2019 June 25]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745.

Kotipalo T. Are you ready for stricter rules for software as a medical device under the new MDR in EU? Tips available! Innokas Medical Ltd; 2019 Feb 15 [Cited 2019 June 25]. Available from: https://blog.innokasmedical.fi/blog/are-you-ready-for-stricter-rules-for-software-as-a-medical-device-under-the-new-mdr-in-eu-tips-available.