From principles to practice: benchmarking government guidance on health apps

Abstract

Patient-facing mobile health applications (apps) hold the promise to change the way individuals take responsibility for their own health by enabling more effective delivery of health information, allowing better monitoring of symptoms, and encouraging healthier lifestyles. 1 Enthusiasm about the potential of health apps has grown rapidly, generating uncertainty as to who should regulate such apps and how. In most countries, medical device regulation applies only to a subset of high-risk health apps that have well defined medical purposes. However, most health apps available on the market target a wide range of healthrelated issues, including diet and exercise, pregnancy, and mental health, while still being considered nonmedical devices. These apps can collect a variety of personal data 2 and, because they are designed to affect health, it is important to ensure their safety, validity, reliability, privacy, and security. Many low-quality health apps exist that, as well as providing advice that is incomplete, misleading, or wrong, might also fall short of meeting the expected standards in privacy and security. 3,4 In a 2017 report, the Organisation for Economic Co-Operation and Development (OECD) concluded that the use of low-quality, non-medical health apps raises a wide range of ethical, legal, and governance issues, and pointed to the need for international agreement on minimum standards in quality assurance controls. 5 We examined guidance for the development of safe, secure, and reliable apps issued by data protection authorities in nine OECD countries (see appendix for methodological details). All these authorities had reported guidance relating to mobile apps in response to the 2017 Census of the International Conference on Data Protection and Privacy Commissioners. We also examined guidance by national health authorities in the same nine countries, and international guidance issued by WHO and the European Commission (EC). We did a comparative assessment of the guidance against the qualitative indicators and the principles and best practices set out in the 2013 OECD Privacy Guidelines and the 2016 OECD Recommendation on Health Data Governance (appendix).

The Debate on the Ethics of AI in Health Care: a Reconstruction and Critical Review

“…Data Sharing/Data Privacy (Kalkman, Mostert, Gerlinger, Van Delden, & Van Thiel, 2019) (Olimid, Rogozea, & Olimid, 2018) (Parker, Halter, Karliychuk, & Grundy, 2019) (Quinn, 2017) (Richardson, Milam, & Chrysler, 2015) (Townend, 2018) Secondary use of Healthcare Data (Lee, 2017) (Nittas, Mütsch, Ehrler, & Puhan, 2018) (O'Doherty et al, 2016 Surveillance, Nudging and Paternalism (Maher et al, 2019) (Marill, 2019) (Nebeker et al, 2017) (Morley & Floridi, 2019d) (Burr, Mariarosaria, & Floridi, 2019) Consent (S. Millett & O'Leary, 2015) (T. Ploug & Holm, 2016) (Mann, Savulescu, & Sahakian, 2016) (Balthazar, Harri, Prater, & Safdar, 2018) Definition of Health Data (Floridi et al, 2018) (Voigt, 2019) (Holzinger, Haibe-Kains, & Jurisica, 2019) (Kleinpeter, 2017) Ownership of Health Data (Chiauzzi & Wicks, 2019) (Krutzinna, Taddeo, & Floridi, 2018) (Shaw, Gross, & Erren, 2016) (Sterckx, Rakic, Cockbain, & Borry, 2016) (Stephan Millett & O'Leary, 2015 Embodied Intelligence/Robotics (Fiske, Henningsen, & Buyx, 2019) Digital Divide/eHealth Literacy (Celi et al, 2016) (Kuek & Hakkennes, 2019) Patient involvement (Aitken et al, 2019) (Page, Manhas, & Muruve, 2016) Patient Safety (Barras, 2019) Evidence of Efficacy (Ferretti, Ronchi, & Vayena, 2019) ...…”

Digital Psychiatry: Ethical Risks and Opportunities for Public Health and Well-Being

“…Healthcare services and governments across the globe have responded to these developments [75], [76]. For instance, the American Psychiatric Association has designed an evaluation framework to guide informed decision-making around the use of smartphone apps in clinical care [6].…”

The Mobile Health App Trustworthiness Checklist: Usability Assessment

“…So far, regulatory bodies such as the US Food and Drug Administration have been more concerned about the safety of mHealth apps that purport to be medical devices or their accompanying add-ons [ 9 ]. The wellness app space lacks quality assurance frameworks and clear guidance from respective authorities [ 10 ]. In light of the relaxed regulatory approach to mHealth apps, evaluation tools have been proposed to assist end users in determining which apps are safe or secure and, thus, which can be trusted [ 11 , 12 ].…”