The AI Act is not in force yet. On 14 June 2023, the Members of the EU Parliament adopted Parliament's negotiating position on the AI Act.

With the Access Prescription Digital Therapeutics Act, we may witness a change that promises to transform healthcare delivery with benefits for both digital health companies and millions of American citizens.

France has introduced a fast-track market access pathway for DTx and digital health products, adding to similar schemes in neighboring EU countries Germany (DVG for DiGA) and Belgium.

Italy’s data protection authority has ordered OpenAI to stop processing people’s data locally with immediate effect. The Italy DPA claims that ChatGPT is breaching the GDPR due to unlawful data processing.

Sharing data for the purposes of data analysis can have huge benefits. The question is how to do so in a way that protects privacy.

Many digital health companies, afraid of the costs and timeline of a proper GDPR implementation, opt for a strategy to store personal and sensitive data inside the devices, hoping to circumvent the regulation.

After the invalidation of the previous adequacy decision on the EU-US Privacy Shield, the US is still considered TODAY a Third country without an Adequacy Decision according to GDPR.

The EU is preparing the world’s first proposal for regulating AI. This new regulation will likely become a global gold standard and a blueprint for other nations outside the EU.

Privacy can limit the amount of available data in healthcare. Sometimes, it seems like it is not possible to benefit from the AI advantages while keeping intact and safe patients’ data.