Policy Reflections on digital health
Stephen Ayre A *A Tasmanian Health Service South, Level 3, Block E, Royal Hobart Hospital, Hobart, Tas. 7000, Australia.
Australian Health Review 46(3) 262-263 https://doi.org/10.1071/AH22128
Submitted: 20 May 2022 Accepted: 20 May 2022 Published: 2 June 2022
© 2022 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.
When I was asked to reflect on policy related to digital health my first thoughts were related to the development of electronic medical records in hospitals, which exploded in the 2000s with rapid development in most Australian public hospitals and some private hospitals.1 The early stuttered starts and failures with enormous costs and setbacks were an issue and then I recalled that more broader developments had been occurring in general practices across Australia in earlier iterations but at a more modest level for some time.
Digital health is much broader than this, however, and includes ‘…categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalised medicine…. Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics).’2
This poses many issues for health care professionals but also for the general public user who have to interpret the information available to them, often using ‘Dr Google’ or relying on health apps, without the benefit of training to sort the evidence presented in a way that is pertinent for their individual circumstances.
The explosion in use of digital technologies has been a challenge for regulators as technology leaps ahead of policy makers creating potential risk of harm. The Therapeutic Goods Administration published on this in 2020, concluding that where regulation does not currently apply the responsibility of adverse consequences from apps falls on individual clinicians3 (and presumably consumers). Subsequently the Therapeutic Goods Administration has published guidance for software based medical devices excluding most mobile apps, as these are seen as sources of information or tools to manage a healthy lifestyle.4
Connectivity is enhanced with digital technology, but poses additional risks to privacy and further challenges for regulators, particularly with devices communicating with other devices or systems and the ease of interactions across national and international borders.
The advances with the use of digital health have progressed significantly in the global pandemic allowing opportunities for hospital avoidance and home-based care, rethinking the possibilities for our health systems.5–7 Telehealth and telemedicine is now more achievable and indeed more acceptable to patients.
We can be optimistic about the future and the opportunities that digital health affords. Policy should shape our response to technology enhancing the possibilities and ensuring safety while not reducing the possibilities.
References
[1] Sullivan C, Staib A, Ayre S, Daly M, Collins R, Draheim M, Ashby R. Pioneering digital disruption: Australia’s first integrated digital tertiary hospital. Med J Aust 2016; 205 386–9.| Pioneering digital disruption: Australia’s first integrated digital tertiary hospital.Crossref | GoogleScholarGoogle Scholar | 27809727PubMed |
[2] US Food & Drug Administration. What is Digital Health? Available at https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health
[3] Australian Government, Department of Health, Therapeutic Goods Administration. Regulation of software based medical devices. Available at https://www.tga.gov.au/regulation-software-based-medical-devices
[4] Australian Government, Department of Health, Therapeutic Goods Administration. Actual and potential harm caused by medical software. A rapid literature review of safety and performance issues. TGA Version 1.0, July, 2020. Available at www.tga.gov.au/resource/actual-and-potential-harm-caused-medical-software
[5] Tasmanian Government. COVID@home program. Available at https://www.coronavirus.tas.gov.au/families-community/covidathome-program
[6] Thornton J. The “virtual wards” supporting patients with covid-19 in the community. BMJ 2020; 369 m2119
| The “virtual wards” supporting patients with covid-19 in the community.Crossref | GoogleScholarGoogle Scholar | 32499317PubMed |
[7] Oliver D. David Oliver: The pandemic has delivered clinical service innovations worth keeping. BMJ 2021; 373 n1306
| David Oliver: The pandemic has delivered clinical service innovations worth keeping.Crossref | GoogleScholarGoogle Scholar | 34039590PubMed |