Discover the significance of GDPR compliance in life sciences and learn key strategies for ensuring data privacy and protecting sensitive information.
Within a data-driven world, the life sciences sector is one of the leaders tapping into enormous pools of data to foster its research, development and patient care affairs. Although this abundance of information is a double-edged sword, Having access to such data comes with an important responsibility of protecting from the data breaches and using for illegal activity sensitive, private and private identity information.
This piece is part of a broader exploration of data privacy and GDPR complicity in the life sciences sector.
Life Sciences: A Wealth of Data
The life sciences sector has an unprecedented opportunity to leverage data for the pursuit of scientific discovery, drug invention, clinical studies, and efficient care. Examples of the billions of data being produced include patient records, genetic information and clinical trial data. This data is not only valuable for research, but also sensitive and confidential, hence there is a need to have proper data privacy practices in place.
Patient Privacy
In life sciences, data privacy is of utmost importance. Under the HIPAA, protected health information (PHI) includes medical records, treatment and genetic information. An improper use or disclosure of PHI can have serious consequences, not only for patients but also for organizations discovered to be in violation of privacy regulations.
Clinical Trials
Central to drug development and investigations in clinical research are, of course, clinical trials. They gather comprehensive information from the participants, including medical and treatment history and adverse events. Maintaining the confidentiality and privacy of trial participants is not just a legal obligation, but also key to keeping trust alive and allowing participation.
Genetic Data
The sheer volume of genetic data, which will be collected in healthcare with the increasing availability of genetic sequencing, continues to increase. Such data is extraordinarily personal because those numbers can not only say a lot about what your health looks like right now but might hint at how robust the gene pool lurking under the hood of your meat wagon makes you. Data security is key for patient trust, and ethical research.
GDPR: Data Privacy Law of the European Union
The enforcement date of GDPR in May 2018 and the presence of personal data widely across life sciences has a substantial effect, as well. Although it is a regulation founded in the European Union (EU), it has worldwide extraterritorial reach affecting any organizations processing EU citizens’ data, irrespective of where it resides.
How the GDPR impacts life sciences
1. Consent and Transparency
GDPR requires explicit and informed consent under the GDPR framework to process any personal data. This affects life sciences in particular, clinical trials and research involving patient data to a great extent. Furthermore, the organizations should be transparent on data utility and purpose.
2. Data Minimization
The basic principle is data minimisation — if any information that exists can be used to identify an individual, then organisations should only collect what they really need and for that limited purpose. In the life sciences, a domain in which data is often collected, businesses should scrutinize whether all data being collected is necessary and avoid ‘data hoarding’.
3. Security Measures
One of the most important requirements for GDPR compliance is data security. Data breaches should be protected with appropriate technical and organisational measures by organisations. However, since healthcare information is highly sensitive and it also includes genetic data, security mechanisms must be strong.
4. Data Subject Rights
Under the GDPR, certain rights are provided to individuals with regard to their personal data such as rights of access, rectification and erasure. For organizations with large data stores, complying with these rights are difficult. You need systems and processes in place to handle those data subject requests quickly.
Life Science: Navigating GDPR compliance
Compliance Costs are a concern, but also an opportunity ensuring GDPR Compliance In life sciences is a proactive and enterprise-wide approach. These six steps can enable organizations to successfully negotiate the regulatory environment.
1. Data Mapping and Inventory
Start With Data You Collect, Where It Is Situated and what it does. A Full Data Inventory form the Base for GDPR compliance. Catalog the data sources: electronic health records, clinical trial data and genetic databases.
2. Privacy Impact Assessments / PIAs.
Privacy Impact Assessments (PIA) to assess the dangers of your data processing operations. While this enables them to identify potential harms on privacy, it makes it possible for developers to implement techniques to prevent such outcomes.
3. Consent Management
Establish concrete Consent management procedures to keep your users informed. They give explicit consent when there is a data processing activity going to be done on their behalf. This is important to take into consideration, particularly in the sphere of clinical trials and research studies.
4. Data Security
Ensure that you have the latest data security such as encryptions, access controls and constant security audit. Data breaches can cause serious legal and reputational damages.
5. Data Subject Rights Handling
Create procedures for effective data subject rights requests. It also provides for the right to data access and erasure.
6. Training and Awareness: Once a year?
Train your employees on GDPR compliance and best practices for data privacy. Keep educating through regular trainings and awareness programs. This helps in keeping the culture of data protection on its feet.
The Path to Compliance
GDPR compliance in the data-rich world of life sciences is complex, but possible. Any organization that sets out on developing longitudinal health data monitoring initiatives can utilize data privacy principles and compliance measures to unlock the potential of data for scientific discovery while still protecting the rights of individuals. In short, GDPR compliance is about more than legal obligation — it offers the chance to establish trust with patient and participant stakeholders.
Conclusion
As a life science industry quality and regulatory consulting firm, we know the specialized challenges associated with attaining GDPR compliance. Leveraging our experience, we provide the policies and practices you need to work within regulatory boundaries while promoting innovative research, as well as protecting those who share their data. Data privacy is intended to be a cornerstone of responsible and trustworthy scientific advancement in the healthcare future that is driven by data.
Learn more about how we assist life sciences organizations by contacting BioBoston Consulting today and visiting our headquarters.
