An interview about certifications, requirements, GDPR and MDR with Stefano Lai, Q&R Manager at Henesis.

When it comes to GDPR, the biggest misconception is that compliance is a one-off project and that once you have checked all the boxes, you don’t have to worry about it anymore.

Not taking into account the importance of protecting your users’ privacy and their personal data may damage your brand reputation and get you out of business. We saw companies lose deals in B2B and B2C startups lose partnerships and reimbursement agreements.

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.

Since July 10th you can start again using US service providers like AWS, Google Cloud, and Azure, without any trouble (and additional safeguards). This is thanks to the new Adequacy Decision approved by the EU Commission for the United States.

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.