Top Trends in the European Digital Health/AI Market
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing populations. Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share a timely take on the top 5 life sciences industry trends being shaped by pioneering digital technologies. We are delighted to present a series of insightful interviews with leaders from a diverse digital health ecosystem giving their perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
Pharma Companies in Beijing Free Trade Zone to Benefit from Relaxed Data Transfer Rules
On August 30, 2024, the Beijing Municipal Cyberspace Administration, Beijing Municipal Commerce Bureau and Beijing Municipal Government Services and Data Administration Bureau jointly released the “Administrative Measures for the Data Exit Negative List of the China (Beijing) Pilot Free Trade Zone (Trial)” (Administrative Measures) and the “Data Exit Administration List (Negative List) of the China (Beijing) Pilot Free Trade Zone (2024 Edition)” (Negative List) to facilitate the export of important industry data and personal information out of the country by companies operating in the Beijing free trade zone (FTZ). (more…)
In a Win for Defendants, Illinois Supreme Court Holds That Health Care Exemption Under BIPA Is Not Limited to Patients’ Biometric Information
For the third time in 2023, the Illinois Supreme Court addressed the scope of the Illinois Biometric Information Privacy Act (BIPA) — this time in Mosby v. Ingalls Memorial Hospital. In a unanimous decision, the court held that BIPA’s “health care exemption” is not limited to patients’ biometric information (such as fingerprint scans), but also extends to biometric information collected, used, or stored for healthcare treatment, payment, or operations — regardless of its source.1 This decision also marks the Illinois Supreme Court’s first BIPA-related decision where it adopted the defendants’ proposed interpretation of the statute. (more…)
AI Use in Drug Discovery
Artificial Intelligence (AI) has the potential to revolutionize how we find, develop, and deliver new life-saving therapies.
Join “State of the Art” host and Sidley partner Stephen Abreu as he speaks with Colin Hill, CEO and Co-Founder of Aitia. Together, they discuss the challenges and opportunities AI presents for the pharmaceutical industry, particularly how AI is accelerating the pace of drug discovery and its implications for the future of medicine.
Digital Health and Artificial Intelligence: New Developments From President Biden’s Executive Order
The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare. As AI becomes a pivotal point of innovation for the healthcare industry, digital health healthcare technology developers, private equity sponsors, and other key industry stakeholders should track the regulatory frameworks certain to be developed following this executive order to better inform strategies for developing drugs and devices and assessing deals involving AI.
President Biden Signs Sweeping Artificial Intelligence Executive Order
On October 30, 2023, President Joe Biden issued an executive order (EO or the Order) on Safe, Secure, and Trustworthy Artificial Intelligence (AI) to advance a coordinated, federal governmentwide approach toward the safe and responsible development of AI. It sets forth a wide range of federal regulatory principles and priorities, directs myriad federal agencies to promulgate standards and technical guidelines, and invokes statutory authority — the Defense Production Act — that has historically been the primary source of presidential authorities to commandeer or regulate private industry to support the national defense. The Order reflects the Biden administration’s desire to make AI more secure and to cement U.S. leadership in global AI policy ahead of other attempts to regulate AI — most notably in the European Union and United Kingdom and to respond to growing competition in AI development from China.
ICO Publishes Guidance on Handling Worker Health Data
On 31 August 2023, the UK Information Commissioner’s Office (ICO) published guidance on the handling of worker health data for employers (ICO Guidance). The ICO Guidance aims to provide tips and good practice advice about how to comply with applicable data protection legislation such as the UK GDPR when collecting and processing worker health data. Helpfully, the ICO Guidance also contains various checklists to help employers assess data protection considerations when processing worker health data.
EU, U.S., and UK Regulatory Developments on the Use of Artificial Intelligence in the Drug Lifecycle
Globally, the rapid advancement of artificial intelligence (AI) and machine learning (ML) raises fundamental questions about how the technology can be used. Drug approval authorities are now also taking part in this discussion, resulting in emerging and evolving guidelines and principles for drug companies.
Washington State Enacts My Health My Data Act, Broadly Regulating Health-Related Data With a Private Right of Action
On April 27, 2023, Washington Gov. Jay Inslee, a Democrat, signed into law the state’s My Health My Data Act (the Act), which will become effective on March 31, 2024 (June 30, 2024, for small businesses). Despite its name, this is a comprehensive privacy bill that will affect many entities, including those outside of the traditional “health” context. The rights and obligations may apply to individuals other than Washington residents, as the law defines consumers as including persons whose data is merely collected or otherwise processed in the state.
FemTech Has Been Warned: UK’s ICO Indicates Closer Scrutinization of FemTech Apps
On 4 April 2023, John Edwards, the UK’s Information Commissioner, stated that the UK’s Information Commissioner’s Office (ICO) would be “going after providers of women’s health apps and auditing them, and getting them to change any practices that are non-compliant.” Speaking at the IAPP Global Privacy Summit in Washington DC, the Information Commissioner indicated that this proposed strategy forms part of the ICO’s new “agile” initiative, which will focus on “areas of vulnerability, targeting…intervention [where] that has the greatest impact”.
