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Guidelines & Legislation

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The Guidelines & Legislation section brings together compliance guidance, best practice resources and support materials to help you navigate legal, ethical and regulatory requirements. 

To access online training and competency tests, please visit the Online Training section.

Submit a Guidelines Query - If you have a question that is not answered in the BHBIA's guidance materials, you can submit it to our Ethics Advisor and receive a confidential response. Only available to full BHBIA members (you will need to be logged in to access the form. Submit a Guidelines Query

 

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NEW - Using AI Ethically in Business Intelligence

This guidance focuses on the ethical issues specific to AI, rather than the broader legal, compliance, privacy and governance requirements that must be followed.

NEW - AI and Adverse Event Reporting

Artificial Intelligence (AI) can support adverse event (AE), product complaint (PC) and special reporting situation (SRS) processes, but it does not change existing pharmacovigilance (PV) obligations, reporting requirements or accountability.

NEW - General Guidance on AI and Data Governance

Many AI tools retain information through conversation histories, workspaces, uploaded files and memory features. While experience gained from previous work is not itself a conflict of interest, confidential information from one client must never be disclosed or inappropriately used for another. Users should therefore understand and manage how AI tools store and access information.

ICO AI & Data Protection Risk Toolkit

This toolkit is designed to provide practical support to organisations to reduce the risks to individuals' rights and freedoms cause by ther own AI systems.

MRS: AI Guidance and using related technologies

MRS has produced this guidance to help practitioners act legally and ethically when using AI and related technologies.

Ethics and Compliance Committee Winter Update 2025 - 4th December 2025

Hear our Ethics Experts discuss their view on the impact of legislative changes in 2025, with a specific focus on the impact of AI technologies.

Legal and Ethical Guidelines for Healthcare Data Analytics

BHBIA guidelines are designed to help us all reduce risk, improve performance and make life a little simpler by drawing key information together in one place.

Ethics & Compliance Committee Webinar Dec 2023 – The Final Word

ECC member Yuliya Fontanetti presented the “Compliant Use of AI” session in the committee’s wrap up of the year webinar. Members can access the recording and slides.

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