Pharma and Healthcare are probably the most regulated domains in the world. They have boundaries and what they can do and how they can do it. After all, they are dealing with our health, our life. All research is done with one purpose: to make people’s lives better in the quest to extend them. But even though this is a very noble meaning to their professional life, everything is highly regulated in this domain.

Electronic documents, forms and prescriptions, need to be signed and exchanged with different regulatory bodies, each having different requirement. European Medicines Agency, DEA, FDA, 21 CFR Part 11 requests trustworthy systems, identity proofing, non-repudiation, legal equivalence with wet signatures. Remember, healthcare is dealing with life, everything must be fully protected. In that light, many companies have implemented at least two types of credentials for signatures and user authentication which becomes complicated and costly to run.

Patient data is becoming more and valuable on the dark market, thus making Pharma and Healthcare more and more attractive for hackers. During the last two years Pharma and Health Insurance companies were hit by major data breaches with no sophisticated attacks. Health data is essential for both patients and companies, it is the core of both their existence, thus protecting health data is vital.

If you look at the „wall of shame” (the Department of Health and Human Services' HIPAA Breach Reporting Tool website) most of the breaches are due to unauthorized access. Implementing solutions for giving the right people proper access, monitoring and having at the same time the legal enforceability of their action is no longer complicated in the age of AI.

Compliance, security, intellectual property and assets protection are the basic needs that can be solved using one particular digital identity.

The EU qualified and SAFE-BioPharma compliant digital certificate for electronic signature is a powerful solution that gives data integrity, non-repudiation and secure identification of the signatory at the same time. Basically this is the equivalent of the passport for the digital world, allowing the free movement and acceptance of the same signature without border.

How can this type of digital certificate address that? By its key properties:

  • Legal enforceability – we know for sure who is behind the certificate because someone checked the identity of the signatory before the issuance of the certificate. Moreover the signatory is legally responsible for his actions (signatures, access) because of non-repudiable property
  • Regulatory compliance – fully compliant with European Medicines Agency, DEA, FDA, 21 CFR Part 11 requirements
  • Strong Security – two-factor authentication mechanisms based on certificates have the high level assurance
  • Global acceptance – digital signatures based on this certificate are accepted in USA and EU with the same legal effect as wet signatures

Safe and enforceable access to information in a sector with open sharing and collaborative culture can be quick at the same time. These certificates are cloud stored and highly protected. No more tokens, drivers, installation - just click and sign!

Remember, when dealing with vital information it is important that the information is accurate kept in 100% safety conditions. Complicated procedures built to ensure safety are sometimes their own enemy, as many times they tend to be simplified, with steps skipped by the users. Data protection needs to be simple on the user’s end, so that it becomes reflex.

Should need some advice on how to implement these technologies, do not hesitate to contact me at viky.manaila@transsped.ro