Connected Compliance for Your Healthcare Facility
Why Healthcare Compliance is Now a Top Priority
Doctor's offices, hospitals, MVZs, and pharmacies are under pressure: GDPR, NIS2, and professional secrecy (§ 203 German Criminal Code) demand the highest security standards. Violations mean:
- Fines of up to €20 million or 4% of annual turnover
- Criminal Consequences (prison sentences of up to 1 year)
- Loss of patient trust
- Existential Risks from NIS2 Violations
The question is not "if," but "how quickly" you become compliant.
Compliance in Care: Examples of Data Collected
- Name, address, and contact details of the patient and relatives
- Social Security Number
- Health insurance provider
- Care level
- Information about illnesses
Our Compliance Solutions for Healthcare
External Data Protection Officer: Industry-experienced experts for medical practices, hospitals & MVZs – legally compliant with Art. 37 GDPR
ISMS Setup & Operation: NIS2-compliant security and ISO 27001 certification
Digital Compliance Platform Proliance 360: ROPA management, processor management, TOM documentation, reporting processes – all in one place
Compliance Audits: Gap analyses and preparation for regulatory audits
Employee Training: GDPR and information security training, as well as AI usage training for medical staff
Individual Consulting: Personal contact with healthcare industry expertise
What you can do right now
You have any questions? Let's get started!
What customers in your industry have to say
Advice that suits you and works in everyday life
We create tailor-made service packages tailored to your company size, your processes and your goals. Together, we implement data protection and information security in such a way that they are legally secure, understandable and practicable in day-to-day business.
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Still have questions? We have the answers
Yes! Modern GRC platforms automate: risk assessments via questionnaires, task workflows, deadline monitoring (GDPR deletion periods, NIS2 reporting obligations), document generation (RoPA, TOM documentation), and dashboards for management. This saves 60–70% of manual work. Proliance 360 integrates data protection and information security in one platform with AI-powered suggestions.
The NIS2 directive mandates stricter cybersecurity measures for healthcare facilities, classified as critical infrastructure (KRITIS). These include risk analyses, incident response plans, reporting obligations for security incidents, and regular audits. Hospitals must demonstrate technical and organizational measures (TOM) by autumn 2024. Proliance 360 supports with NIS2 readiness checks, automated risk assessments and compliance dashboards. Combine NIS2 with GDPR requirements in healthcare for comprehensive protection.
Recommended Certifications: ISO 27001 (Information Security), ISO 27701 (Privacy Extension), Certification according to TISAX® (Automotive Suppliers), KRITIS-B3S (Healthcare Industry Standard). Proliance accompanies clients from the ISO GAP analysis, through the step-by-step ISMS development, to audit preparation. Combine the ISO 27001 Consulting with GDPR Consulting for dual compliance assurance.
Digital Health Applications (DiGA) must comply with high data protection and information security standards according to DiGAV and Section 139e SGB V: end-to-end encryption, data minimization, consent management, and GDPR-compliant data processing agreements. The BfArM reviews these requirements in a fast-track procedure. Proliance offers DiGA audits, gap analyses, and documentation templates.
Hospital networks and MVZ structures require central governance: uniform ISMS guidelines, shared responsibility models, consolidated risk registers, and multi-tenant GRC tools. Clarify responsibilities for shared IT systems and data processing agreements. Proliance 360 offers multi-tenant architecture for network structures with central reporting and local implementation autonomy. More information: Data Protection in Healthcare for care facilities within a network.
Do you have any further questions or would you like a personalised consultation? We are happy to help.