The EU AI Act: Guardrails for trustworthy, transparent AI in pharma and life sciences

Historically, patient trust in doctors created stability in healthcare operations. This trust extended to science and prescribed treatments, improving acceptance and effectiveness. While the system is complex, its success stemmed from the foundational confidence among patients, providers, and the medical community.

AI use in pharma is an innovative game-changer, but it could also be equally destructive to patient and HCP trust. The EU AI Act aims to retain that trust.

Regulating AI in healthcare: How does the EU AI Act impact pharma?

It’s a wild west out there now. AI is reshaping nearly every facet of drug development and healthcare delivery. It is being used to identify disease targets, optimize clinical trials, design new drug molecules, with many more applications. The EU AI Act is the new sheriff on a global stage. It’s armed with a legal framework for AI use to ensure safe, transparent, and trustworthy AI systems. It is a regulation designed to avoid impeding the pace of innovation in healthcare and life sciences by over-regulating AI use on products with little risk to individuals. Conversely, the EU AI Act is designed to heavily scrutinize high-risk AI use in industry sectors—particularly pharma.

The EU AI Act risk categories are:

1. Prohibited AI Systems (Unacceptable Risk)
2. High Risk AI Systems
3. Limited Risk AI Systems
4. Minimal or No Risk AI Systems

How will the EU AI Act build trust in AI for healthcare?

Pharma falls square in the High Risk AI Systems category, defined as having direct impact on health, safety, and fundamental rights. When all elements of the EU AI Act are rolled out in 2027, patients and healthcare providers (HCPs) should be comforted by Act provisions that focus on trust. Transparency, Documentation of Assumptions, Instructions for Use (IFU), and Human-in-the-Loop are EU AI Act requirements that help open the black box of AI use within pharma today. There will also be increased governance on data quality and data mitigation to protect against AI models that are trained against unrepresentative or poor-quality data.

Five actionable steps pharma companies should take now to prepare for EU AI Act compliance

The EU AI Act is the first of many AI regulations expected to be implemented. Here are five actions pharma companies should adopt now to prevent possible disruption to their product pipeline.

1. Conduct an Audit of Internal AI Tools: Know which AI applications, including those involving third-party dependencies such as software providers, contract research organizations (CROs), and other external partners, that would be categorized as high risk.
2. Strengthen Data Governance: Review existing standing operating procedures (SOPs) for data quality and bias mitigation requirements. Are they sufficient? Processes for data collection, cleaning, etc., will have increased scrutiny when AI tools are applied. In particular, stress-test explainability for any clinical or regulatory AI applications to ensure outputs can be clearly justified to patients, healthcare professionals, and regulators.
3. Design Human Oversight into Every AI High Risk Application: Insufficient explainability and/or documentation will only delay EU AI approval.
4. Assign a Team for Post-Launch Monitoring and Reporting: EU AI scrutiny will continue beyond the development stage to include monitoring products post-launch. Consider assigning an AI officer and creating a compliance committee to oversee adherence.
5. Build AI Literacy Among HCPs and Other Stakeholders for Medical Product Development: Transparency builds trust.

Just as the implementation of GDPR and Article 57 demanded rigorous preparation and ongoing vigilance, so too will the EU AI Act require pharma organizations to balance the pace of innovation with disciplined and sustained compliance. New regulations inevitably create pressure on teams that are already stretched thin. This underscores the importance of thoughtful preparation and early plans for structured support. Protecting the trust of patients and HCPs to ensure adoption of products produced through use of generative AI makes compliance not simply a legal necessity but a strategic enabler.

Drawing on deep experience in life sciences regulatory transitions, Escalent Implementation Consultants are uniquely positioned to provide embedded, scalable support for life sciences companies navigating the ever-changing regulatory landscape with confidence. We turn regulatory readiness from a source of strain into a foundation for accelerated and innovative growth.

Meet our authors

Tim C. Taylor, VP, Life Sciences, Escalent
Sanjeev Jha, Director, Life Sciences, Escalent
Dee Eden, Group Strategy Director, Hall & Partners