Data Protection Solutions For Life Sciences - Newsletter #32

Regulations & Guidelines

­­

GDPR Omnibus Reform 

­The European Commission's proposal to amend the GDPR aims to harmonize enforcement across Member States, clarify complaint handling, and enhance procedural rights for companies. Key changes include unified enforcement for life sciences companies, clearer procedures for investigations, and stronger rights of defense. The reform does not alter core GDPR principles but seeks to streamline compliance and reduce regulatory risks, particularly benefiting organizations involved in multinational clinical trials and health data processing.

­ Click to read more­

Australian OIAC Updates APP Guidelines 

­The Office of the Australian Information Commissioner has updated the Australian Privacy Principles Guidelines to reflect changes from the Privacy and Other Legislation Amendment Act 2024. Key updates include new obligations for automated decisions in privacy policies, a new exception for cross-border disclosures, and clarified reasonable steps for information security and destruction.

­ Click to read more­

EU Approves Draft Data Protection Adequacy Decision for Brazil

­The European Data Protection Board has adopted an opinion supporting the European Commission's draft decision on Brazil's data protection framework, allowing free personal data transfers between Europe and Brazil while ensuring strong safeguards. Brazil's data protection law is seen as closely aligned with EU legislation, though clarifications are needed on certain points like Data Protection Impact Assessments and onward data transfers, providing legal certainty for organizations involved in data transfers.

­ Click to read more­

EU Streamlines Cross-Border Data Protection Complaint Handling

­The Council has adopted new regulations to enhance cooperation among national data protection authorities, streamlining the handling of cross-border GDPR complaints. Key changes include harmonized admissibility criteria, a maximum investigation time of 15 months (extendable to 27 months for complex cases), and a simplified cooperation procedure to ease the administrative burden for straightforward cases.

­ Click to read more­

AI & Techbio

­­

Drugmakers Share Data to Power Foundation Models

­Big pharmaceutical companies like Eli Lilly are sharing machine learning models trained on proprietary data to accelerate drug discovery while ensuring data privacy. Lilly's TuneLab offers biotechs access to ML models focused on safety and pharmacokinetics, inspired by the MELLODDY consortium. While ML-assisted drugs show high success rates in early phases, challenges remain in efficacy and data scarcity. The industry is moving towards integrating multimodal data and autonomous AI systems, potentially democratizing drug discovery and shifting strategies from data hoarding to collaborative ecosystems.

­ Click to read more­

Mental Health Companies Turn to AI Chatbots to Expand Access to Care

­Mental health companies are increasingly developing AI chatbots to meet rising patient demand, with nearly 50% of Americans having used AI for mental health support. These chatbots are designed to complement human therapists, providing 24/7 support and directing users to professional help when necessary, while ensuring clinical supervision and training with anonymized therapy transcripts.

­ Click to read more­

BioTech, Healthtech and Healthcare

­­

FDA Awards Record ADC Review Designations

­The FDA awarded a record 63 review designations for Antibody Drug Conjugates (ADCs) in 2024, reflecting a strong commitment to advancing this cancer treatment technology. ADCs, which combine monoclonal antibodies with cytotoxic drugs, have seen a significant increase in designations from 7 in 2019. Enhertu, by Daiichi Sankyo, received the most designations at 34, showcasing its potential across multiple cancer types.

­ Click to read more­

Multilingualism: A Potential Key to Extending Healthspan

­Speaking multiple languages may extend healthy aging by up to 3 years, with multilingual individuals being 2.2 times less likely to experience accelerated aging compared to monolinguals. This protective effect is consistent across age groups, and learning new languages could be as beneficial as physical activity or quitting smoking.

­ Click to read more­

Podcasts 

‍

­­

­

iliomad's News

­

We Were At AI For Health Paris

­

iIliomad Health Data was at the AI for Health Summit in Paris.  We shared how we support biotech, medtech, clinical research, and data platforms with AI, and unveiled new capabilities designed to help life sciences teams move faster and stay compliant.

­ Click to read more

‍