Pharma/Life Sciences Archives

The UK Cyber Security and Resilience Bill

Background

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European Union (EU) NIS 1 Directive when the UK was a member of the EU.

A key driver behind the UK government’s plans is a desire to stay broadly aligned with evolving EU legislation, particularly with the significant expansion in scope of the new EU NIS 2 Directive. Once presented to Parliament, the Bill could become law by early 2026.

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How We Spent Our Summer Vacation or Summary of CCPA Amendments

The long anticipated amendments to the CCPA were passed by the California Legislature in early September and now await Governor Newsom’s signature. Some of the changes were “clean up” amendments to update cross references, standardize language, and generally address issues of drafting. What follows is a summary of the most significant and substantive amendments:

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FDA Expands Big Data Use with Sentinel System

The U.S. Food and Drug Administration (FDA) is increasing its capability to harness the power of big data – or more specifically of the “real world evidence” (RWE) – to assess the safety of medical products that are approved for the U.S. market. To that end, FDA is expanding its Sentinel System so that by the end of 2023 it would represent “a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making,” according to the recently released Sentinel System Five-Year Strategy.

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England’s National Health Service Long Term Plan Envisions NHS-wide Adoption of Digital Tools

The National Health Service (NHS) oversees health services in England, and under that government’s direction sets strategic objectives for the health care system as a whole. The other constituent countries of the United Kingdom (UK) – Scotland, Wales and Northern Ireland – similarly have their own public-health agency each. Any UK resident may obtain health services through any of these independent organizations – either for free or at a much lower price than through a private provider.

Last year, NHS celebrated its 70th anniversary. The milestone prompted a national conversation about the role and future of that organization. In part in response to that debate, the agency prepared and recently released “The NHS Long Term Plan,” outlining its vision for servicing public health in the next decade. A previous strategic document, “NHS Five Year Forward View” (2014), created a foundation for the current planning by setting in motion some of the initiatives that are now being projected to be spread to the entire system.

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FCC Moves Ahead with Connected Care Pilot Program Notice of Inquiry

The Federal Communications Commission (FCC) announced its intention to launch a $100 million pilot program to provide greater access to health care for rural and low-income Americans, as well as veterans, through the use of telehealth last month. The FCC is now moving forward with a Notice of Inquiry (NOI), which will kick off a comment period on the proposed program.

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US FDA Approaches to Artificial Intelligence

Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital, to market research at a benefits management organization, to optimizing manufacturing operations at a pharmaceutical company. The level of regulatory scrutiny of such systems depends on their intended use and associated risks.

In the U.S., for medical devices using AI, one of the key regulatory bodies is the Food and Drug Administration (FDA), especially its Center for Devices and Radiological Health (CDRH). CDRH has long followed a risk-based approach in its regulatory policies, and has officially recognized ISO Standard 14971 “Application of Risk Management to Medical Devices.” That standard is over 10 years old now, and therefore is currently undergoing revisions – some of which are meant to address challenges posed by AI and other digital tools that are flooding the medical-devices arena.

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Category: Pharma/Life Sciences