Confidentiality & Seal

Makrolife Biotech



At Makrolife Biotech GmbH, we prioritize the confidentiality and security of our customers’ data and samples. By engaging with our services, all information and materials provided by our clients are automatically protected under a non-disclosure agreement (NDA). This ensures that no details about the testing, results, or any proprietary information are shared with third parties or other clients under any circumstances.

Our laboratory premises are designed with the highest safety and security standards.









Confidentiality and Data Security






Access to our facilities is strictly restricted to authorized personnel only, and third parties are not permitted entry. To further enhance security, our laboratories are equipped with camera surveillance systems, ensuring continuous monitoring and control. Each sample entrusted to us is handled with the utmost care and remains under strict confidentiality protocols throughout the testing process.

We are committed to providing our clients with the assurance that their sensitive data and intellectual property are safeguarded at every stage. With limited staff access and robust security measures in place, we maintain a secure environment that upholds the trust and integrity of our partnerships. At Makrolife Biotech, your data is not only tested with precision but also treated with the highest level of confidentiality.


In Germany, there are several laws and regulations that govern confidentiality and data protection, particularly for businesses and laboratories. Here are some key regulations



1. General Data Protection Regulation

(GDPR - EU Law)


  • Overview: Although a European Union regulation, GDPR applies in Germany and governs the processing and protection of personal data. It ensures that companies handle customer data securely and with explicit consent.
  • Relevant Articles:Article 5: Principles of data processing (e.g., confidentiality, integrity).
  • Article 32: Security of processing (e.g., ensuring data confidentiality).
  • Article 9: Special categories of personal data, such as health data.
  • Key Point for Laboratories:Requires strict control over how personal and sensitive data (e.g., test results) is processed and stored.


2. Federal Data Protection Act

(BDSG - Bundesdatenschutzgesetz)


  • Overview: The BDSG complements the GDPR in Germany, focusing on national specifics for data protection. It reinforces obligations for confidentiality and data security.
  • Key Sections:§ 26 BDSG: Protection of employee data (important for laboratories with internal staff).
  • § 42 BDSG: Penal provisions for breaches of confidentiality.
  • Key Point for Laboratories:Stipulates additional requirements for handling sensitive data, such as personal health-related information or proprietary client data.


3. German Trade Secrets Act (Geschäftsgeheimnisgesetz - GeschGehG)


  • Overview: This law regulates the protection of trade secrets and confidential information.
  • Definition of Trade Secrets:Any information that has commercial value, is confidential, and is subject to reasonable measures to protect it.
  • Obligations for Laboratories:Prohibits unauthorized sharing of proprietary client data, processes, or testing results.
  • Requires companies to take reasonable steps to secure trade secrets (e.g., access controls, NDAs).
  • Penalties for Breach:Violations can lead to civil claims for damages and criminal penalties.



4. Labor Law Confidentiality Obligations (Arbeitsrechtliches Verschwiegenheitsgebot)


  • Overview: Employees in Germany are obligated by labor law to maintain confidentiality about business-related matters.
  • Key Aspects:Employees must not disclose proprietary or sensitive information obtained during their employment.
  • Specific confidentiality clauses can be included in employment contracts for additional legal protection.
  • Key Point for Laboratories:Staff with access to customer samples or data must adhere to strict confidentiality rules.


5. Medical Devices Act

(Medizinproduktegesetz - MPG)


  • Overview: For laboratories working with medical products or health-related tests, this act mandates the confidentiality of test data and results.
  • Key Requirements:Laboratories must ensure that test results and related personal data are not disclosed without explicit consent.
  • Key Point for Laboratories:Handling of health-related test data must comply with high standards of confidentiality.


6. Criminal Code

(Strafgesetzbuch - StGB)


  • § 203 StGB: Breach of Confidentiality of Professional SecretsProfessionals, including laboratory personnel, are legally required to maintain confidentiality regarding sensitive information obtained during their work.
  • Applicability: This applies to health professionals, scientists, and anyone handling confidential client or patient information.
  • Penalties: Breaches can result in fines or imprisonment.


7. Good Laboratory Practice

(GLP - OECD Principles Adopted in Germany)


  • Overview: GLP outlines standards for non-clinical laboratory studies, ensuring the integrity of test data.
  • Key Points:Laboratories must ensure data security, prevent unauthorized access, and maintain data confidentiality.
  • Requires secure documentation and storage of test results.


8. Product Liability Act

(Produkthaftungsgesetz - ProdHaftG)


  • Overview: Laboratories and companies must ensure that product-related data, including test results, is handled securely to avoid risks or liability.
  • Key Aspect for Laboratories:Confidential handling of test results ensures protection against misuse or liability claims.

These laws collectively ensure that customer data, testing results, and proprietary information are handled securely and confidentially in Germany. Compliance with these regulations not only protects your business but also builds trust with clients. Let me know if you’d like a deeper dive into any specific regulation!






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