# IEEE Ethical Assurance


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**Sub-Commitee:** Digital Mental Healthcare for Behavioural Change)
**Contact:** [[e-mail]](mailto:[e-mail])
**Date:** 6th April 2022
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**Summary**
This sub-committee will explore issues related to trust and explainability when using or deploying technologies that intervene on the mental health or well-being of users. This will include technologies that generate automated recommendations to healthcare professionals (e.g. decision support for assessment or diagnosis), as well as other commercially available technologies, such as smart devices or novel forms of VR for therapy and behavioural change.
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## Agenda

1. Welcome and Introductions
- Christopher Burr (Alan Turing Institute)
- Roa Powell (Alan Turing Institute)
2. Scope of Sub-Committee
- Digital technologies used in formal healthcare systems
- This appeals, as when you broaden it to the commercial domain - a lot of focus is on clinical efficacy. If you focus on products that are already clinically effective, there is more room to focus on other ethical concerns.
- Commercialised us and wellbeing apps are very different from formal healthcare. This could be an arena where we could have most impact from a legal perspective. The blurry sector of wellbeing is highly underregulated. Many manufacturers go the easy way of circumventing approval to become a 'medical device'.
- One option is to focus on the border between formal healthcare and informal and how there is a lack of standardisation on what should or should not fall into the spectrum of devices which are highly regulated.
- Digital technologies used in any environment
- Particular type of behaviour or mental health issues
- Common mental health disorders (e.g. depression and anxiety), PTSD, dementia or alzheimers, aphasia
- National or international
- Differences between national ecosystems
- UK: NICE
- EU: EU legal framework, medical device regulation enshrines that depending on risk category, all mental health devices will fall into risk class 2a which means there are high requirements for evidence, conformity assessments, third parties. Beyond this, any specificity is determined on a national level.
- For these rules to apply - the manufacturer can decide whether it should count as a medical device.
- US:
3. Objectives of Sub-Committee
- Identify areas amenable to the development of ethical standards or standards that support ethical goals.
- Identify case studies for in-depth study of how ethical standards might apply to technologies for behavioural change
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4. Resources
- [Zotero library for shared research](https://www.zotero.org/groups/4656696/ieee_ethical_assurance_behavioural_change/library)
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## Minutes