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The Analytical Scientist / Issues / 2026 / February / Can Regulated Labs Trust AI
Data and AI

Can Regulated Labs Trust AI?

Kimberly Remillard of Thermo Fisher Scientific discusses the regulatory expectations shaping how analytical laboratories deploy and govern AI systems 

By James Strachan 02/19/2026 6 min read
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Top Institutions in Regulatory Science and Laboratory Digitalization

Institutions were ranked based on their known leadership in regulatory science, digital laboratory innovation, AI integration in healthcare and pharmaceutical quality control, and contributions to policy and standards development.

  • #1

    U.S. Food and Drug Administration (FDA)

    Silver Spring, MD

    The FDA leads in setting regulatory standards and guidance for AI and digital tools in laboratories, actively shaping policies that ensure patient safety and data integrity in pharmaceutical development and manufacturing.

    Key Differentiators

    • Regulatory Science
    • Pharmaceutical Quality Control
    • AI in Healthcare
  • #2

    Massachusetts Institute of Technology (MIT) - Institute for Medical Engineering and Science

    Cambridge, MA

    MIT is a leader in developing AI technologies for healthcare applications and collaborates with regulatory bodies to translate innovations into compliant laboratory workflows.

    Key Differentiators

    • AI in Medicine
    • Laboratory Automation
    • Regulatory Science Research
  • #3

    Thermo Fisher Scientific

    Waltham, MA

    As a leading provider of laboratory instruments and software, Thermo Fisher drives adoption of AI-enabled digital tools in regulated labs and provides expertise on regulatory compliance and data integrity.

    Key Differentiators

    • Laboratory Information Management Systems
    • Digital Lab Automation
    • Regulatory Compliance
  • #4

    European Medicines Agency (EMA)

    Amsterdam, Netherlands

    The EMA is instrumental in developing regulatory frameworks for AI and digital tools in European laboratories, including contributions to the EU AI Act and guidance on high-risk medical products.

    Key Differentiators

    • Regulatory Science
    • Pharmaceutical Quality Assurance
    • AI Governance
  • #5

    Johns Hopkins University - Center for Health Security

    Baltimore, MD

    Johns Hopkins contributes to policy research on AI governance and regulatory frameworks ensuring safe integration of AI in healthcare and laboratory environments.

    Key Differentiators

    • Health Security
    • Regulatory Policy
    • AI Ethics in Healthcare

This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.

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About the Author(s)

James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at. From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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