In 1350, people were dying of the plague, and doctors didn’t know how to treat them. That sucks, but medicine wouldn’t exist if they couldn’t have kept trying and failing. That’s where we are.
That was the time the fda got far more rights to sanction and sue medical manufactures and I think we are in a better world for that.
The new law explicitly says what liability it wants to add:
* death or personal injury, including medically recognised psychological harm;
Whether software (including apps) was covered under the existing PLD has always been controversial.i For instance, there is controversy as to whether software should qualify as a product in the sense of the directive, ii or whether it is part of either the services or of the intangible goods category, iii which falls outside the scope of the existing PLD. iv
i) D. Wuyts, The product liability directive – more than two decades of defective products in Europe, 2014, and BEUC position paper on the Review of Product Liability Rules, 2017.
ii) See Article 2 of the existing PLD. A product has to be distinguished from a service and must be understood as 'all movables even if incorporated into another movable or into an immovable'.
iii) See pages 53-54 of the Commission staff working document on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, 2018: 'The definition of "product" as per article 2 of the Directive is related to the concept of "movable". This has been interpreted as meaning that only tangible goods shall be considered products [...] the non-tangible nature of some new technological developments (software, applications, Internet of Things, Artificial Intelligence systems) makes it difficult to classify them as products rather than services'.
iv) K. Alheit, The applicability of the EU Product Liability Directive to software, 2001. EPRS | European Parliamentary Research Service 6
* property damage, while removing the threshold of €500 and the possibility for Member States to impose a financial ceiling of €70 million; and
* loss or corruption of data that is not used exclusively for professional purposes
You don't even have to do it flawless, you still have the same defences available as in other product liabilities:
* the defect did not exist when they placed the product on the market;
* or the state of technical knowledge at the time of placing the product on the market made it impossible to discover the defect (i.e., the 'development risk defence').
We all buy medical devices and the companies are fully liable for them and they contain software, so it is quite possible to build software without getting sued.
see:
https://www.europarl.europa.eu/RegData/etudes/BRIE/2023/7393...
edit: formatting