Navigating the Digital Health Ethics Landscape: A framework for understanding ethical principles for digital health

Executive summary

We have created an interactive version of the executive summary that you can use to click-through to the sections of the guidelines you would like to read more about:

Introduction

Within a couple of decades, digitally-enabled practices have become prolific across our work and lives and are the norm. These transformations have largely been driven and controlled by commercial organisations, however there is increased interest and participation from health and medical research charities which see the potential benefit to patients.

Charities hold a unique position of trust, and therefore have a mandate to embody best practice in the use of digital technologies and any interactions these may have with people’s data. To enable this, the AMRC commissioned DataKind UK to develop an ethics framework for members to reference when developing and deploying digital products and services. The result being this paper, as well as a guide for enacting this framework when collaborating with industry partners through a series of questions: ‘Navigating the Digital Health Ethics Landscape: Questions for charities to ask digital technology company partners’.

There are a wealth of existing ethical principles that are to some extent applicable, but not specific to, the digital health work of charities. Hence, these various frameworks were collated and relevant aspects from across all of them were developed into this single framework.

Understanding the context

The first step in the process was to characterise the environment in which health and medical research charities work when undertaking digital health research.

This can be represented as the sectors they might interact with:

Nine core principles

Existing ethical principles in each of these areas were identified and parsed to tease out consistencies across them that are relevant to charities developing health technologies.

Nine key concepts materialised:

Beneficence	Do work that is to the benefit, not detriment of people. The benefits of the work should outweigh the potential risks.
Non-maleficence	Avoid harm. This is closely related to beneficence.
Autonomy	Enable people to make choices. This requires people to have sufficient knowledge and understanding to decide.
Justice	The benefits and risks should be distributed fairly.
Explicability	Transparency around how and why digital health solutions generate the outcomes they do. Particularly relevant to AI, for which the assumptions, working and outputs should be explicable.
Sustainability (financial and operational)	Minimise risk of developing digital products and services which users become dependent on but cannot be sustained.
Open research	Commitment to make research freely open and accessible for reuse.
Community mindedness	Willingness to collaborate within the digital health community, such as sharing platforms applicable across medical conditions.
Proportionality	Being proportionate to the relevant risk and potential benefit.

Appendix A: Methodology

Introduction

The AMRC commissioned DataKind UK to develop a usable ethics framework for members to utilise when developing and deploying digital technology products and services. Members of the AMRC have expressed concerns in partnering with tech start-ups and large corporations; in particular there is an awareness that charity values may be side-lined in the absence of clear, firm ethical guidelines for the partnership. In digital projects, charities may have less control and less ability to interrogate their products without specialist tech expertise, and may run the risk of losing control of data under their stewardship in a way that is irreversible, with consequent risks of harms for beneficiaries and the charity itself.

Support was required to:

Define the ethical challenges faced by health and medical research charities in digital and data - which can be addressed by existing codes applied to unfamiliar disciplines and which require a different language
Signpost to relevant existing frameworks
Identify best practice that overcomes these challenges, including basic questions to ask of potential commercial and technology partners
Develop an ethical framework that charities can use.

AMRC leadership was keen to use work from others in digital, health, and other fields to help charities bring their ethical values to partnerships in digital health, rather than creating yet another code of ethics unnecessarily. This has the advantage of learning from a diverse range of experts and experiences, as well as (it is hoped) aligning with ethical assessments that may be conducted by academic partner review boards or government stakeholders, and minimising any extra bureaucratic load caused by ethical reporting during project development.

The section below presents the methods used which enabled the project to reach the stated objectives.

Method

A: To gain an understanding of the context and challenges in which health and medical research charities work within, we relied on:

discussions with AMRC;
our existing knowledge of healthcare and digital development;
the discussion document ‘Promoting More Effective Partnerships’ created by senior AMRC member executives; and

stakeholder interviews encompassing six AMRC members already involved in digital/data projects, and seven ethics experts from different fields. See Appendix B for a list of all participants and Appendix C for interview guides.

This information was used to develop the core areas in which to frame the digital health ethical landscape for charities, and enabled us to understand which possible principles/frames were relevant for charities that were developed in other disciplines.

B: Signpost to relevant existing frameworks.

DataKind UK collated and reviewed 63 ethical resources which was used as a menu to pick and choose the ethical frames which were suitable for digital health. This spreadsheet is available here. The resources were collected by:

using existing knowledge from work DataKind UK undertook to develop ethical principles for its volunteer community of data scientists
internet research covering digital app development, AI, digital health, bioethics and medicine, public health, non-profit ethical frameworks. For any resource found, its references were further inspected for other inputs.
suggestions from stakeholders during their interviews about key relevant resources.

C & D: Identify best practice that overcomes challenges, including basic questions to ask of potential commercial and technology partners and develop an ethical framework that charities can use.

Through stages A and B, we were able to create a frame for understanding ethics within digital health for health and medical research charities. The next step was to bring these high-level values to AMRC and charity representatives active in digital health, to discuss the validity of the framework and how they might lead to operational questions to ask tech partners.

A workshop was held with eight AMRC members and staff from the AMRC (a list of participants are provided in Appendix B to discuss the framework; present principles that represent the framework and additional principles which could be included (see Appendix D); and develop ways to apply it through questions to ask tech partners. A link to the presentation used can be found here.

The workshop participants engaged in small-group discussions about the various principles identified as framing their ethical position, and as a group built a consensus around nine principles which were relevant to the sector. Participants agreed to split the principle of open research and community mindedness – which had been presented as a single principle – into to two distinct concepts. Whilst most alternative principles were discussed as already being incorporated within the core nine (for example diversity, inclusion and equality should be a core feature of justice), one alternative received mixed reactions from the group as to whether it should be a distinct principle.

Some codes of ethics and principle sets break out the need to be evidence-driven, which requires decisions to be made on the basis of evidence, including evidence around the other ethical principles (e.g. evidence for benefit, evidence for fairness and justice). Clear consensus was not found on whether this should be a separate principle, or whether it should be integrated within all other principles. Having looked at the questions to ask partners to test whether having a separate principle for Evidence-Driven projects brought value, we have found that questions around evidence can naturally be incorporated into the other principles as appropriate, and so operationally it is not crucial. As such, this has not been included as an independent principle in this initial framework - but the AMRC and individual charities may decide to reassess this in future, as it is possible that in some projects a separate requirement for evidence will improve the project outcomes and the understanding between partners.

Following agreement about the high-level principles, the next step of the workshop was to develop questions that could be asked of tech partners to investigate ethical risks and ways to address them, in any project. Workshop participants were given a case study and in small groups developed questions to ask of partners around each principle. After the workshop, we merged these questions with other questions from AI and tech governance projects in various sources, to provide a range of options for AMRC member charities. The questions to ask partners document is available here.