Title: Tri-jurisdiction Convergence Exposes Healthcare AI Buyers to Unexamined Decisions; Straven & Co Offers Independent Validation Protection
What is happening?
The FDA (United States), MHRA (United Kingdom), and Health Canada have aligned their principles for good machine learning practice in healthcare, outlining the necessary steps to ensure trustworthy artificial intelligence (AI) is implemented throughout the sector. This convergence demands that buyers of AI solutions carefully scrutinize claims before committing to a technology that may not deliver as promised.
Why it demands action now?
Regulated organisations face three significant risks when buying and deploying AI in healthcare: capability risk, governance risk, and liability risk. Capability risk arises from the uncertainty surrounding an AI’s performance against real-world operations. Governance risk stems from an organisation’s inability to defend its decision-making process when faced with regulatory scrutiny or legal action. Liability risk lies in the organisation being accountable for any errors or adverse outcomes caused by the AI.
Action:
To mitigate these risks, a prudent healthcare AI buyer should take three strategic steps: (1) conduct a thorough review of the AI solution’s claims and capabilities; (2) assess its governance and legal exposure to ensure compliance with regulatory requirements; and (3) test the technology against real-world operations to verify its effectiveness.
How Straven & Co helps:
Straven & Co offers independent validation services, providing organisations like yours with peace of mind when evaluating AI solutions. By examining an AI’s capability against a healthcare organisation’s real operations, people, governance obligations, and legal exposure, we deliver a plain verdict: proceed, proceed with conditions, or do not. Our independence is key to this process, as we have no product to sell and earn nothing by recommending more AI solutions – this ensures our verdict can be trusted.