Industries · Healthcare & life science

Healthcare and life science: sensitive data, strict rules, one chain of evidence.

Health data, research and supplier contracts, medical device deadlines and NIS2. Paragraf connects the contracts, the requirements and the evidence, so Legal, Quality and Security work from the same truth.

NIS2GDPRMDR / IVDRAI Act

Research agreement · Clause 9

  • TopicData protection
  • Your positionData stays in the EU
  • StatusAccepted
  • Approved byData protection officer
Product example

The pressure

Every contract touches something sensitive.

Health data is a special category

GDPR sets stricter rules for health data, and NIS2 covers healthcare providers and pharmaceutical manufacturers.

Deadlines that don't move

Medical devices must meet MDR by the end of 2027 or 2028, depending on class. Every supplier and document in the chain needs to be ready.

Counterparty paper everywhere

Research, trial and supplier agreements often arrive on the other party's template, and each one needs the same careful review.

A practical example

Example: a sponsor sends a research agreement.

Step 1 of 4

Checked against your playbook.

The agreement is compared with your positions on data protection, publication rights and IP. Each deviation shows the clause it comes from.

Review · Research agreement

  • Deviations2
  • Highest riskData transfer
  • SourceClause 9.3
Product example

For the buying group

What each role gets.

One foundation, so each role sees its own part – and everyone sees the same truth.

  • LegalAgreements reviewed against your own positions, with sources.
  • Quality & regulatoryRequirements and supplier evidence in one model.
  • Data protectionPersonal data clauses approved and followed up.
  • SecurityNIS2 duties with owners and evidence.

Before you decide

The questions that usually hold teams back.

Changing how work is followed up is a real decision. Here is how we make it a safe one.

Patient data can't leave our environment.

Then it doesn't have to. Paragraf can run on your own servers with local AI, or be hosted in the EU. Everything follows your permissions.

Do we have to change our quality system?

No. Keep it. Paragraf follows up the contracts, requirements and evidence around it, and links to what you already have.

Can we trust AI with this?

You decide where AI is used. Every suggestion shows its source, a person approves, and every step also works without AI.

Where do we start?

With one contract type, for example research or supplier agreements, with acceptance criteria agreed up front.

Next step

Fewer systems.
More control.

Book a walkthrough with one of your own agreements. We show you the review, the approval and the follow-up, on your material.