SRC – Your partner for certifications in the healthcare sector
The healthcare sector is a highly complex system with strict requirements for data protection, availability and integrity of sensitive data. SRC Security Research & Consulting GmbH supports companies in this area with comprehensive security audits and certification services. Our focus is on the assessment of IT security in order to meet legal and regulatory requirements.
Our core competencies in healthcare certification
SRC is a recognized testing body for various security-related requirements in the digital health sector. We offer independent testing and expert opinions for:
✔ TR-03161 test – IT security assessment for digital health applications (DiGA & DiPA) according to the requirements of the BSI.
✔ Security assessment for gematik – Proof of security suitability for telematics infrastructure products.
✔ Product expert opinion for gematik – Assessment of the security, interoperability and functionality of products in the healthcare sector.
✔ Audits according to § 8a BSIG – Security audits for operators of critical infrastructures (KRITIS) in the healthcare sector.
Why are IT security audits crucial in healthcare?
The digitalization of the healthcare sector brings numerous opportunities, but also challenges. Legal requirements increasingly demand an independent security assessment in order to protect sensitive patient data and ensure the approval of regulatory products.
With our expertise, we offer manufacturers and operators of digital health solutions a reliable basis for testing and certification – from the initial safety assessment to final approval.
Our services at a glance
- Testing & certification in the healthcare sector – We guide you through the entire certification process in accordance with TR-03161 and gematik guidelines.
- Security analysis & vulnerability assessment – Identification and elimination of security-critical gaps in digital health applications.
- Advice on IT security strategy – support in the development of secure digital healthcare solutions.
- Preparation of expert reports for gematik – security reports and product reports for regulated and non-regulated healthcare applications.
- KRITIS audits according to § 8a BSIG – Support for operators of critical infrastructures in the healthcare sector in fulfilling legal security requirements.
