3.0 Ethical, legal and regulatory considerations
Framework structurePrimary domain 3, ethical, legal and regulatory considerations, is shown in this section.
Legislative systems are currently unable to match pace with the rate of advancement of new digital technologies. There are also many ethical concerns surrounding the use of technologies such as Artificial Intelligence (AI) in society, especially in medical care. Such tools have the potential to increase or continue to reflect pre-existing biases and inequalities, as well as increase the digital divide for some people. To address these concerns, ethical and regulatory frameworks and considerations should be at the forefront of decision making regarding the application of AI and digital technology in order to promote equity, fairness and transparency.
Capability statement - I champion a culture of ethical responsibility around the use of Artificial Intelligence (AI) and digital technology to ensure that systems and processes are fair, transparent, equitable and non-discriminatory to patients, staff and the wider public; espousing the principles of beneficence, non-maleficence and autonomy.
Archetypes:
- Shaper
- Driver
- Creator
Capability statement - I know how to access up to date guidelines and knowledge about digital systems at the point of care and only use such systems I am trained and competent to use, recognising my own limitations and competence.
Archetypes:
- User
Capability statement - I always ensure that appropriate consent for data sharing has been granted prior to processing, storing or sharing data.
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of ethical considerations around information governance for digital health technologies including remote consultations/monitoring (for example, consent, recording of consultations and sharing of images).
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the ethical issues of automating clinical decision making or relying on algorithms and digital technology that are not fully transparent/understandable.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware that data collection tools and systems should be designed to account for patient/user diversity so that the output of data processing/analysis will not cause or increase health inequalities.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the need for citizen consent and am fluent in the reasons and actions taken to protect and enshrine public trust.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I champion a culture of ethical responsibility around the use of Artificial Intelligence (AI) and digital technology to ensure that systems and processes are fair, transparent, equitable and non-discriminatory to patients, staff and the wider public; espousing the principles of beneficence, non-maleficence and autonomy.
Archetypes:
- Shaper
- Driver
- Creator
Capability statement - I know how to access up to date guidelines and knowledge about digital systems at the point of care and only use such systems I am trained and competent to use, recognising my own limitations and competence.
Archetypes:
- User
Capability statement - I always ensure that appropriate consent for data sharing has been granted prior to processing, storing or sharing data.
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of ethical considerations around information governance for digital health technologies including remote consultations/monitoring (for example, consent, recording of consultations and sharing of images).
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the ethical issues of automating clinical decision making or relying on algorithms and digital technology that are not fully transparent/understandable.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware that data collection tools and systems should be designed to account for patient/user diversity so that the output of data processing/analysis will not cause or increase health inequalities.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the need for citizen consent and am fluent in the reasons and actions taken to protect and enshrine public trust.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I abide by legal requirements and directives regarding the access to and processing of data (for example, General Data Protection Regulations, Data Protection Act 2018).
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the potential litigious consequences of a data breach to my organisation (for example, fines, damage to reputation) and actively take steps to prevent this by abiding by my organisations standards and guidelines.
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the legal, ethical and accountability implications for my organisation of using Artificial Intelligence (AI) for augmented clinical decision making.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am aware of the legal, ethical and accountability implications for myself and organisation when following or overruling AI based recommendations in augmented clinical decision making.
Archetypes:
- User
Capability statement - I am aware that legislation may not keep pace with technological innovation. Where clear regulations do not exist I aim to apply the ethical principles of beneficence, non-maleficence, autonomy and justice as a guide to using digital technology (for example, promoting principles of privacy, confidentiality and equality).
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am familiar with the governance requirements (including UK Conformity Assessed (UKCA/UKNI), CE marking) for medical devices including software and AI concerning regulation, quality management, testing and ongoing monitoring.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of clinical evaluation frameworks (for example, International Medical Device Regulators Forum (IMDRF) recommendations, National Institute for Health and Care Excellence (NICE) evidence standards framework for digital health technologies) that can be used to clinically evaluate software and AI as a medical device.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am aware of how to determine if a given automated system has been appropriately validated for use in its intended clinical context and has undergone a clear, transparent approval process.
Archetypes:
- Driver
- Creator
- Embedder
Capability statement - I am aware of issues around consent and medical negligence (for example, Bolam, Bolitho, Montgomery v Lanarkshire) and the challenges of applying these to AI and digital technologies.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I understand regulatory approval does not guarantee the performance of a medical device or algorithm in any given context.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the different wearable remote monitoring devices and ensure that when recommended to patients they have appropriate regulatory approval (for example CE, UKNI or UKCA mark).
Archetypes:
- Driver
- Embedder
- User
Capability statement - I abide by legal requirements and directives regarding the access to and processing of data (for example, General Data Protection Regulations, Data Protection Act 2018).
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the potential litigious consequences of a data breach to my organisation (for example, fines, damage to reputation) and actively take steps to prevent this by abiding by my organisations standards and guidelines.
Archetypes:
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the legal, ethical and accountability implications for my organisation of using Artificial Intelligence (AI) for augmented clinical decision making.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am aware of the legal, ethical and accountability implications for myself and organisation when following or overruling AI based recommendations in augmented clinical decision making.
Archetypes:
- User
Capability statement - I am aware that legislation may not keep pace with technological innovation. Where clear regulations do not exist I aim to apply the ethical principles of beneficence, non-maleficence, autonomy and justice as a guide to using digital technology (for example, promoting principles of privacy, confidentiality and equality).
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am familiar with the governance requirements (including UK Conformity Assessed (UKCA/UKNI), CE marking) for medical devices including software and AI concerning regulation, quality management, testing and ongoing monitoring.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of clinical evaluation frameworks (for example, International Medical Device Regulators Forum (IMDRF) recommendations, National Institute for Health and Care Excellence (NICE) evidence standards framework for digital health technologies) that can be used to clinically evaluate software and AI as a medical device.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
Capability statement - I am aware of how to determine if a given automated system has been appropriately validated for use in its intended clinical context and has undergone a clear, transparent approval process.
Archetypes:
- Driver
- Creator
- Embedder
Capability statement - I am aware of issues around consent and medical negligence (for example, Bolam, Bolitho, Montgomery v Lanarkshire) and the challenges of applying these to AI and digital technologies.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I understand regulatory approval does not guarantee the performance of a medical device or algorithm in any given context.
Archetypes:
- Shaper
- Driver
- Creator
- Embedder
- User
Capability statement - I am aware of the different wearable remote monitoring devices and ensure that when recommended to patients they have appropriate regulatory approval (for example CE, UKNI or UKCA mark).
Archetypes:
- Driver
- Embedder
- User
Page last reviewed: 14 February 2023
Next review due: 20 February 2024