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Compliance that enables market access and protects health data.

GDPR, ISO 27001, and NIS2 impose strict requirements for data protection and information security. heyData consolidates tasks, documentation, and experts on a single platform.

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What is included?
GDPR, NIS2, ISO 27001 & more
Experts with healthcare know-how
All frameworks on one platform
Patient data securely protected
YOU KNOW THIS

In the healthcare sector, compliance is part of the product

Missing evidence slows down approvals.

For DiGA and other regulated offerings, data protection and information security must be implemented in a verifiable manner. Incomplete documentation wastes time and jeopardizes market access.

Health data requires more protection.

Health data is among the most sensitive types of information. Legal bases, DPIAs, access rights, and security measures must therefore be documented with extra precision.

Enterprise deals fail due to security questions.

Clinics, insurance providers, and major partners often require robust security proof – such as an ISMS, clear controls, and audit-ready evidence. Without these, audits and sales cycles drag on.

What heyData does for healthcare & medtech.

From data protection and information security to audit preparation: heyData connects requirements, tasks, and documentation in one guided system.

DATA PROTECTION

GDPR for health data

Create and maintain records of processing activities, TOMs, DPIAs, and data processing agreements through guided workflows – with support from industry-experienced data protection experts.
DPIA
ROPA
INFORMATION SECURITY

Implement ISO 27001 in a structured way

Build your ISMS with a risk register, controls, tasks, and evidence. Existing documentation can also be used for other frameworks.
ISMS
Annex A
DIGA & REGULATORY

Prepare DiGA requirements

Structure your data protection and information security documentation according to the relevant requirements and prepare your files for the BfArM approval process.
DiGA
BfArM
VENDOR MANAGEMENT

Manage service providers securely

Keep track of data processors, sub-processors, contracts, risks, and documentation in one central place – with clear responsibilities and automated reminders.
DPA
Art. 28 GDPR
AUDIT & DOCUMENTATION

Audit-ready at all times

Policies, risks, measures, and evidence are structured in one place – for customer audits, due diligence, and regulatory inquiries.
Audits
Due Diligence
COMPLIANCE TRAINING

Targeted team training

Assign role-based data protection and security training. Completions and reminders are documented centrally.
Security Awareness
Evidence
WHY HEYDATA

What our customers say

2,500+ customers trust heyData with their information security.

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With heyData, we save time, reduce risks, and actively strengthen our customers' trust.

Lara Schimweg
Founder & CEO, Xeno GmbH

Thanks to the platform, we can handle onboarding centrally and efficiently.

Benjamin Azadi
Manager Health Policy, Chiesi GmbH

What sets heyData apart is its responsiveness and fast execution.

Sandra Scherzer
Legal Team, Bioland

The software helps us document all IT security measures relevant to data protection and review them regularly.

Dennis Kuhlmann
CEO, KUMA IT-Solutions GmbH
FAQ

FAQs

Can't find what you're looking for? Our team will get back to you within one business day.

Ask our team

What special obligations apply to health data?

Under Art. 9 GDPR, health data belongs to the special categories of personal data. Depending on the processing, you'll need, among other things, an appropriate legal basis, enhanced security measures, and often a Data Protection Impact Assessment. heyData helps you document the requirements in a structured way.

What do we need for a DiGA application?

For the DiGA process, you must be able to demonstrate compliance with the applicable data protection and data security requirements. Which specific evidence is required depends on the product and procedure. heyData supports you in building and maintaining the documentation in a structured way.

How long does ISO 27001 certification take with heyData?

That depends on your scope, company size, and existing security structure. With heyData, you're audit-ready faster because tasks, evidence, and responsibilities come together in one place instead of being scattered across different tools and Excel files. In the quick check, we'll give you a realistic assessment of your starting position.

What evidence do hospitals and health insurers expect?

The requirements differ depending on the partner and the processing. Frequently requested items include data protection agreements, TOMs, risk assessments, security policies, and a traceable ISMS. heyData keeps this evidence centralized and up to date.

Does NIS2 apply to every healthcare or medtech company?

No. Whether NIS2 applies depends, among other things, on the activity, company size, role in the supply chain, and national implementation. heyData supports you with the initial assessment and with setting up the required risk, security, and evidence processes.

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