{"id":20505,"date":"2026-11-08T17:51:09","date_gmt":"2026-11-08T15:51:09","guid":{"rendered":"https:\/\/lamdabroking.com\/?p=20505"},"modified":"2026-11-08T17:51:09","modified_gmt":"2026-11-08T15:51:09","slug":"ai-medical-device-liability-insurance","status":"publish","type":"post","link":"https:\/\/lamdabroking.com\/en\/ai-medical-device-liability-insurance\/","title":{"rendered":"AI-Enabled Medical Devices and Digital Health"},"content":{"rendered":"

A chest X-ray triage tool flags an image as normal. The emergency physician, at the end of a long shift, discharges the patient. Months later a finding that was on the image from the start is diagnosed, and the claim letter is addressed to the company that built the software as well.<\/span><\/p>\n

When AI-enabled medical software makes an error, liability is usually shared between the manufacturer that placed it on the market as a medical device and the clinician or institution that relied on its output. The provider of the training data and the integrator that connected the system to the electronic health record can be drawn in too. For an Israeli medtech or digital health company selling software as a medical device (SaMD) into the US and Europe, the practical question is which policy responds when the same error produces a bodily injury claim and a professional negligence claim at once.<\/span><\/p>\n

This page deals with products already on the market. Baseline cover is explained on our pages on <\/span>insurance for digital health companies<\/span><\/a> and <\/span>life sciences companies insurance<\/span><\/a>.<\/span><\/p>\n

Key points<\/span><\/h2>\n

A claim reaches more than one defendant<\/b>\u00a0– The manufacturer is sued over a design or warning defect and the clinician over negligence. Each turns to a different policy, and the hospital’s insurer may seek contribution from the manufacturer.<\/span><\/p>\n

The usual gap sits between two policies<\/b>\u00a0– Technology errors and omissions (Tech E&O) policies tend to exclude bodily injury, and product liability policies were often written around physical hardware. Software that harms a patient can fall between them.<\/span><\/p>\n

A model that updates changes the risk the insurer underwrote<\/b>\u00a0– A predetermined change control plan (PCCP) settles updates with the FDA. The insurer needs the update mechanism described in the proposal as well.<\/span><\/p>\n

The regulatory clock moves at different speeds<\/b>\u00a0– Regulation (EU) 2026\/1744 moved the AI Act’s high-risk obligations for medical devices to 2 August 2028, while the new Product Liability Directive, which treats software as a product, applies to products placed on the market from December 2026. In the US, the FDA’s overarching guidance on AI-enabled device software is still a draft.<\/span><\/p>\n

The liability chain: who may carry the loss<\/span><\/h2>\n

Four parties can be named when the output of a medical algorithm leads to harm: the manufacturer, the clinical user, the data provider and the integrator. How liability is shared depends on the governing law and the contracts, and on how autonomous the tool is. The more the software decides on its own, the more weight shifts to the manufacturer.<\/span><\/p>\n