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.

In this blog article, we will go through this topic from the POV of a digital health startup and try to give you a better understanding of when you should ask for consent and why.

If you are running a project dealing with personal or sensitive, you may already have heard at least once those three letters: DPO.

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.