BioTech & MedTech
Synthetic Data: the answer to privacy issues?
Synthetic Data could be the answer to many questions about security and privacy. Real world data oftentimes contains sensible data and thus has to be thoroughly protected to respect security and privacy principles. Synthetic data is currently being developed, most notably to answer those questions about security and privacy.
Data Silos And The GDPR
Data Silos are an ongoing problem for many companies but even more so for Life sciences companies. They are most of the time obstacles to an analysis of the data as well as to the accessibility and interoperability of data. It is necessary for companies to have the right tools to de-silo the data. Furthermore, a sound decision making is needed, especially for data concerning EU citizens. The GDPR imposes two principles concerning this data: the data minimisation principle and the purpose limitation. Not all data should be collected and stored. A choice must be made.
The Progress Made For Decentralized Trials
Decentralized trials have privacy and security issues. The development of new technology could help to limitate the security issue, notably by processing patient-generated data securely in real time. Decentralized trials could use edge computing or federal computing. But this still poses some problems for the privacy issues.
Artificial Intelligence
ChatGPT As A Doctor?
ChatGPT passed the United States Medical Licensing Exam (USMLE), an exam required in the US for medical licensure. But is it ready to be deployed in real conditions? An ER Doctor tested ChatGPT with the data that he collected on his patients and evaluated the diagnosis made by ChatGPT. The AI has an important bias and used as such it won’t be able to establish the right diagnostic. It could be used in the future as a tool to help a diagnosis thanks to a multitude of data that it collected over the years.
The problem here is the collection of the patients' health data. Furthermore, to be efficient, it needs many categories of data, such as real world data. The question of the protection of the data has to be made clear.
Europe And AI Involved In The Medical Field
The European Regulators are conscious of the impact of drugs made with the input of an AI. The need for a regulation is apparent. Nevertheless, some warn against over-regulation that could stifle the innovation.
The use of AI still makes many issues apparent. For example, if an AI decides itself which patients can join a clinical trial based on how it expects them to respond to the drugs, many challenges must be faced. First among them are the security and integrity of the data. How would it access the data? How would it make its choice? On what basis? AI is very promising, but it also has to be used prudently so as not to infringe on the rights of the patients.
Digital Therapeutics
Health Apps And The Federal Trade Commission
The past few months many health applications were condemned for sharing their data with advertisers or for mishandling the user's data.
The Federal Trade Commission (FTC) is enforcing the Health Breach Notification Rule which requires vendors of personal health records to notify the FTC and consumers in the event of a breach of unsecured identifiable health information. The FTC could enforce the Rule against BetterHelp and GoodRx thanks to a guidance issued by the U.S Department of Health and Human Services’ Office for Civil Rights (OCR).
Health applications must be cautious with the way they handle data and most importantly how they inform the user about this use.
Regulations
A new data regulation in the United Kingdom
A new bill titled the "Data Protection and Digital Information Bill" is currently being proposed in the United Kingdom. The initial consideration by the Public Bill Committee will be done on the 10th of May. Currently, the Parliament is calling for written evidence. The Bill would change many parts of the existing regime such as the definition of personal data, the processing of data for "legitimate interests", scientific research, the obligations of data controllers and processors or even the international transfers of personal data.
EU's Upcoming Pharmaceutical Legislation
Drug shortages in the cold months are common these last couple years, especially concerning those used in the case of respiratory infections.
The EU has to prepare for the coming months.
Availability accessibility, and affordability are at the center of this upcoming reform of the pharmaceutical legislation.
Sign up for our newsletter
We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
Newsletter #20
🌎 This month, key updates include Brazil’s introduction of a new SCC-based framework for international data transfers. 📋 The EDPB shared its evaluation of the EU-US Data Privacy Framework. 🤖 Advancements in AI-driven health solutions, such as Sanofi’s Muse for clinical trial recruitment, were also highlighted. 🧬 Discussions focused on genomics privacy, neural data protection, and the transformative role of AI in healthcare and compliance landscapes.
Newsletter #19
In October, key developments in data privacy, AI, and cybersecurity emerged, including new GDPR accountability guidance for controllers, the introduction of the UK’s Data Bill 2024, and the FDA's call for coordinated AI regulation in healthcare. High-profile data breaches also highlighted vulnerabilities in health data, underscoring the need for stronger, globally aligned privacy standards.
Newsletter #18
Get up to speed with the latest in data protection regulations and healthtech innovations, including updates from Brazil, the UK, and California, along with advancements in AI-driven healthcare solutions. Plus, explore major privacy enforcement actions and key developments shaping the future of digital health.
