Data Protection and AI Compliance for Biotech
Biotech is revolutionising healthcare, driven by scientific breakthroughs and AI-powered innovation. The COVID-19 pandemic put biological science in the global spotlight, and now, AI is accelerating the development of life-changing treatments.
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But with great innovation comes great responsibility.
Success in biotech depends on more than just groundbreaking research—it requires robust data protection and AI compliance to:
- Protect patient data
- Gain NHS and stakeholder trust
- Attract vital investment
- Mitigate cyber risks that could threaten critical research
Achieving and demonstrating compliance with evolving data protection and AI regulations is complex – but essential. That’s where NormCyber comes in.
Meet NormCyber
As an award-winning provider of data protection and AI compliance expertise, we help biotech companies navigate regulatory challenges with confidence. From risk assessments and compliance frameworks to policy reviews, training, and cyber security solutions, we empower you with the clarity, control, and resilience needed to protect your most valuable asset: data.
Common Data Protection and AI Challenges for
Biotech Companies
Roles and Responsibilities
Understanding your role in relation to the personal data you are processing is crucial in ensuring compliance with the UK and EU GDPRs. Your obligations will vary depending on whether you are a ‘controller’, ‘joint controller’ or ‘processor’.
Privacy
Patients and other individuals have the right to be informed about the collection and use of their personal data. Biotech companies need to know what ‘privacy information’ to provide, when and how.
AI
Now that the EU AI Act is in force, biotech companies wanting to do business in the EU need to understand the roles of ‘Providers’ or ‘Deployers’ – and the differing obligations and responsibilities that go with these rolls, as well as which risk category their product will be classified as.
Investor Confidence
Part of raising money to fund development and research often involves answering difficult due diligence questions from potential investor’s about data protection compliance.
Contracts
Both the UK and EU GDPRs imposes a legal obligation on organisations sharing patient personal data to formalise their working relationship by having a contract in place with required terms, ensuring they each protect the personal data of patients and other individuals; ensure both are clear about their role and responsibilities – and are able to demonstrate this.
Data Transfers
Sharing personal data with other organisations that are outside the UK or EU adds another, sometimes daunting, layer of complexity to contracts.
Risk Assessment
Data Protection Impact Assessments (DPIAs) are a process designed to help systematically analyse, identify and minimise the data protection risks of a project or plan. They are also key to compliance with the EU AI Act. But DPIAs can be very time-consuming and very often are carried out with only a focus on technical security, without much or any consideration given to lawful bases.
Anonymisation and pseudonymisation
Understanding the difference between these, their impact on data protection compliance requirements, and how their use can assist with safeguarding patient personal data is essential.
Research
Knowing when you can use personal data for research.
Customer Success Story:
Brainomix
Brainomix, a leader in AI-powered imaging solutions, appointed NormCyber to ensure full data protection compliance. With our advice, guidance and support, Brainomix can focus on delivering life-saving AI innovations.
Read the full case studyTrusted by Industry Leaders
Biotech and healthcare innovators trust NormCyber for their data protection needs.
“Norm has given us clarity in where we are with our data protection and information security health, and where we need to be as we reach new levels of growth. Robert and his team are extremely knowledgeable and happy to work around our needs in a mindful and pragmatic manner, which makes them feel truly part of our team.”
Melissa Strange
Chief Financial Offer | Brainomix
“Data privacy is a top priority for us, so we knew it was time to bring experts in. Norm was recommended to us, and after speaking with the team, we were ready to try it their way. We haven’t looked back since!”
Alice Facey
Chief of Staff | 111SKIN
