Regulations & Guidelines
Understanding 'sensitive covered data' under the APRA discussion draft
The American Privacy Rights Act discussion draft, which could become the U.S.'s first comprehensive federal privacy law, has been released and is currently being evaluated by privacy professionals for potential operational implications. The draft introduces 18 categories of 'sensitive covered data' that would require heightened protections, including the need for express consent before any transfer to a third party, unless deemed necessary and proportionate.
EU: Multistakeholder Expert Group to Commission publishes evaluation of the GDPR
The Multistakeholder Expert Group observed an upswing in data protection compliance and awareness, but also a deficiency in understanding how to exercise these rights, particularly in relation to automated decision-making. The report drew attention to concerns over applying GDPR principles, potential data portability impact, and challenges in harmonizing GDPR with other regulations like AML obligations and the PSD2.
Revised CTIS transparency rules, historical trials and interim period : quick guide for users
From June 18th, 2024, the updated Clinical Trials Information System (CTIS) and revised transparency rules come into effect. These adjustments decrease the amount of publicly viewable clinical trial documents, providing sponsors with enhanced protection for commercially sensitive information.
Finland: Ombudsman publishes DPO guidance
On June 18, 2024, the Office of the Data Protection Ombudsman published guidelines for organizations appointing a Data Protection Officer (DPO). The guidelines underline the DPO's independence, resource access, early involvement in data protection issues, clear responsibilities, and direct reporting to senior management, and emphasize that the DPO should not have conflicts of interest and that responsibility for determining data processing means and purpose should remain with the controller.
Decentralized clinical trials: Launch of a pilot phase by the DGS, DGOS, ANSM, and CNIL
The European Commission, acknowledging the importance of digital tools in health research, issued recommendations on decentralized clinical trials in December 2022. To address design challenges, a pilot phase is being launched by the French Ministry of Health, the DGS, the DGOS, the ANSM, and the CNIL, running from January to September 2024, where promoters can ask specific questions and receive a response within 15 days.
Minnesota joins US privacy landscape with Consumer Data Privacy Act
On May 24, 2024, the Minnesota Consumer Data Privacy Act (MCDPA) was signed into law, making Minnesota the 19th state to enact comprehensive privacy legislation. The MCDPA applies to organizations conducting business in Minnesota or targeting its residents, and outlines several consumer rights, sets requirements for valid consent, and mandates the provision of clear privacy notices and detailed data privacy policies.
Updating Data Processing Under CNIL: What Are the Steps?
In France, some health data processing activities are subject to preliminary formalities with the CNIL. These activities may change over time. If these modifications affect the implementation methods or the rights of individuals, new procedures with the CNIL may be required.
Data Privacy Enforcement
ICO to investigate 23andMe data breach with Canadian counterpart
The Information Commissioner’s Office (ICO) and the Office of the Privacy Commissioner of Canada (OPC) have initiated a joint investigation into a data breach at 23andMe, a global genetic testing company. The investigation will explore the extent of the breach, the sufficiency of 23andMe's safeguards for the sensitive information it holds, and the adequacy of the company's breach notification to regulators and affected individuals as per Canadian and UK data protection laws.
Consumers advance PharMerica class action over 2023 data breach
PharMerica Corp. must face a proposed class action lawsuit alleging it failed to protect the personal information of over 5.8 million people exposed in a 2023 data breach. Plaintiffs Jaketrius Lurry, Micaela Molina, Holly Williams, and others claim PharMerica did not implement adequate security measures, monitor its network properly, or notify victims in a timely manner, violating state and federal laws.
Biotech & Healthtech
Privacy concerns undermine the potential of female fertility tech start-ups
Fertility and other female health tech start-ups have drawn billions in investment, aiming to tap into a $36 billion market, but privacy concerns threaten their growth. The 2022 US Supreme Court decision to overturn the constitutional right to abortion has intensified these concerns, causing some investors to shy away due to inadequate data privacy measures, and prompting many companies to enhance their privacy policies and shift to freemium business models to regain trust and attract users.
Artificial Intelligence
AI Ethics and governance in practice - the Alan Turing Institute
In 2021, the UK's National AI Strategy suggested the transformation of the Public Sector Guidance on AI Ethics and Safety into a series of practical workbooks. As a result, the AI Ethics and Governance in Practice Programme was developed, consisting of eight workbooks and an interactive online platform. These resources offer comprehensive guidance for AI project teams on how to implement ethical values and practical principles throughout the AI project lifecycle. This is to ensure AI is created and utilized ethically, safely, and responsibly. The core of this guidance is the PBG Framework, which aids AI project teams in ensuring their AI technologies are ethical, safe, and responsible.
The Digital future of pathology
Recent years have brought many AI-based technologies to the practice of pathology. From digitized workflows and deep learning to biotechnology for precision medicine, this article discusses benefits and case studies.
AI integration in dug manufacturing: GMP insights for operational excellence, regulatory compliance
The integration of artificial intelligence (AI) and machine learning (ML) into pharmaceutical manufacturing is transforming how drugs are produced and quality controlled, offering enhanced operational precision, efficiency, and compliance. However, this also brings complex regulatory challenges that must be carefully addressed..
Cough monitoring solutions: The current digital health landscape
Cough, a traditionally difficult to track symptom, can now be examined in detail thanks to new digital health technologies. Specialized hardware and artificial intelligence-based software offer a deeper look into personal coughing habits, benefiting both self-assessment and clinical evaluations. This AI-led progression in cough monitoring could empower patients and enhance clinical assessments, as long as privacy issues are suitably addressed during the development process.
New AI for biopsies can analyze microscopy images, talk to pathologists about your tumor
PathChat, a unique AI model for pathology developed by a Harvard-led team, can analyze images, converse about slides, and draft pathology reports. The model has outperformed others in tasks including diagnosing and answering disease-related questions, showing potential to streamline pathologists' work and provide guidance for rare diagnoses.
FDA Authorizes Prenosis' Sepsis ImmunoScore: The First AI Diagnostic Tool for Sepsis
The FDA has authorized Prenosis' Sepsis ImmunoScore, the first AI diagnostic tool for sepsis, demonstrating AI's potential to enhance patient safety in healthcare settings. This software, integrated into hospital EMRs, improves clinical workflow, decision-making, and patient safety by providing real-time diagnostics, highlighting the emphasis on interoperability and data-driven healthcare.
OWKIN - Opportunities and obstacles for AI in pathology
Over the past year, the integration of AI tools into everyday life and medical applications has increased, though understanding their development, particularly in pathology, is crucial for informed use. AI in pathology enhances diagnostic accuracy, workflow efficiency, and early disease detection by automating routine tasks and analyzing complex tissue patterns, despite challenges such as high setup costs, data security, and ethical considerations.
Data Governance
How to manage the quality of data in a health data warehouse?
The management of data quality in Health Data Warehouses is crucial for effective reuse in care and research. This article outlines three approaches to address data and the quality-centered approach, highlighting data consistency and validation throughout its handling. Each method aims to ensure high-quality data, essential for reliable research and improved healthcare outcomes.
French health data : Up to two and a half years to access data, even with CNIL's green light
With the average wait times reaching 228 days for private research and 284 days for public research between August 2017 and July 2023 the delay to access health dat in France has been judged alarming by the Cour des comptes (the institution in France responsible for auditing the use of public funds). The National Health Insurance Fund (Cnam), which handles "most" data provision, struggles to respond to a growing number of projects due to the complexity of requests, delays in respondents expressing their needs, and insufficient capacity of its information systems to quickly carry out necessary processing.
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MEDI'NOV Spain
We were at the MEDI'NOV Spain healthtech congress in Barcelona to present our latest collaboration with SOPHiA GENETICS.
For the past few months, we have been supporting SOPHiA GENETICS with an exceptional initiative: the UNITY Project. This new data-driven consortium aims to accelerate global cancer research. SOPHiA UNITY seeks to unite leading healthcare institutions to advance cancer research, promote drug development, and support data-driven patient care.
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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.
