Skip to content
Zerod

SOLUTIONS · HEALTHTECH

Compliance and security for healthtech.

Hospitals and health authorities will not sign without seeing ISO 27001, ENS and GDPR. And if your AI touches diagnosis or triage, the EU AI Act classifies it as high risk.

Zerod handles all of it, in a single platform, built for the reality of European healthtech.

Book a DemoTalk to an Expert
A compliance workspace with three active frameworks: ENS at Media category and ISO 27001 implemented, GDPR in progress. Each row carries its scope and its state.

Active frameworks

3 frameworks

FrameworkStatus
  • ENSNational Security FrameworkImplemented
  • ISO 27001Information security managementImplemented
  • GDPRData protectionIn progress

The compliance landscape for healthtech.

Healthtech is one of the most regulated categories a company can enter. The frameworks pile up:

Illustration of the healthtech regulatory landscape: seven frameworks piling up, ISO 27001, ENS Media or Alta, GDPR and LOPDGDD, ISO 27701, the EU AI Act, MDR and HIPAA, each with what it requires.

  1. ISO 27001

    required by hospital procurement, private insurer networks and clinical partners

  2. ENS Media or Alta

    required to sell to Spanish public health services and regional health systems

  3. GDPR + LOPDGDD

    clinical data is special category data with reinforced obligations

  4. ISO 27701

    for organizations that want to demonstrate maturity in their privacy programme

  5. EU AI Act

    AI in diagnosis, triage or clinical decision support is considered high risk

  6. MDR (Medical Device Regulation)

    if your software is a medical device

  7. HIPAA

    if you have US customers or handle American patient data

Public and private healthcare customers do not ask whether you have certifications. They ask you to prove it.

What healthtech customers really want to see.

Illustration of the three healthtech buyer types and what each one requires before signing: hospital and public health procurement, private clinics and health insurer networks, and investors in healthtech scaleups.

  • Hospital and public health procurement

    • ENS (typically Media)
    • ISO 27001
    • Security questionnaires

    Spanish public health services, hospital networks and health innovation programmes will not move a contract forward without ENS certification (typically Media) and, increasingly, ISO 27001. Procurement teams send security questionnaires with dozens of items. Without a Trust Center or a continuous compliance strategy, answering them manually, case by case, takes weeks.

  • Private clinics and health insurer networks

    • ISO 27001
    • GDPR
    • DPO, RoPA and DSAR
    • Breach management
    • Pentest reports

    These are profiles that are especially sensitive to GDPR and to clinical data governance. They expect ISO 27001, an internal DPO function, RoPA, DSAR workflows and demonstrable data breach management. Some ask for pentest reports before signing.

  • Investors in healthtech scaleups

    • Cybersecurity maturity
    • Data governance
    • AI Act readiness

    Fund due diligence now covers everything from cybersecurity maturity to data governance and AI Act readiness. In these cases, "we will do it later" no longer works.

How Zerod fits into the healthtech workflow.

  • Multi-framework by design: Most healthtech companies need ISO 27001 + ENS Media + operational GDPR + often the EU AI Act. Zerod maps controls across all of them, so evidence collected once serves every certification. What used to be four separate consulting projects becomes one unified programme.
  • Clinical data governance built in: Special category data under GDPR requires reinforced controls: an explicit legal basis, a DPIA obligation for high-risk processing, and often codes of conduct. Zerod’s GDPR module handles all of this natively, with no additional module required.
  • AI in healthcare, under the AI Act: If your product uses AI in diagnosis, triage or clinical decision support, it is probably high risk under the EU AI Act. Zerod's AI Act module records your systems' classification, filters the 27-control register by it, and generates the Article 9 policy and the Article 72 post-market monitoring plan.
  • Trust Center to support sales: A public Trust Center that automatically answers most external security questionnaires. When a hospital procurement team asks about your security posture, you send a link, not a 40-page document.

Healthtech companies that trust Zerod.

Digital health platforms, telemedicine providers, clinical AI companies and healthtech scaleups across Europe use Zerod to manage compliance and validate security continuously, so their engineering teams keep building and their sales teams keep closing.

What matters to your customers is outcomes. And Zerod lets you show the outcome of your compliance programme, so all the work you put in shows.

Get compliant. Prove your security.

Book a DemoTalk to an Expert
Healthtech · Zerod