Regulators

Wales Leads in Genomics Through NHS and Illumina Collaboration
Digital Health Wales Leads in Genomics Through NHS and Illumina Collaboration

Wales is positioning itself as a leader in genomics following a groundbreaking collaboration between the NHS in Wales and Illumina, a prominent science technology company. This partnership will enhance ongoing research into lung cancer diagnostics and aims to expand into other cancer types and

How Will New EU Health Tech Rules Impact Medical Device Supply?
Regulatory & Compliance How Will New EU Health Tech Rules Impact Medical Device Supply?

The European Union has recently rolled out significant amendments to its Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) with the goal of addressing potential supply chain disruptions that could jeopardize the availability of medical devices and diagnostics. These

Supreme Court Sidesteps Texas Abortion Case Amid Federal Conflict
Regulatory & Compliance Supreme Court Sidesteps Texas Abortion Case Amid Federal Conflict

The Supreme Court's refusal to hear an emergency abortion case from Texas has highlighted the ongoing legal and political battle over abortion rights across the United States. Utilizing its discretionary power, the high court has left in place a lower court's ruling, which allows Texas to

Are PBMs and Pharma Companies Driving High Insulin Prices?
Regulatory & Compliance Are PBMs and Pharma Companies Driving High Insulin Prices?

The rise in insulin prices has become a heated topic in healthcare discussions, drawing scrutiny towards the roles played by pharmacy benefit managers (PBMs) and pharmaceutical companies. Recently, Texas Attorney General Ken Paxton has taken a significant legal step by suing major PBMs and pharma

How Will the EU AI Act Impact Life Sciences and Digital Health?
Regulatory & Compliance How Will the EU AI Act Impact Life Sciences and Digital Health?

New regulations often elicit a mix of anticipation and apprehension, and the EU AI Act is no exception, especially in the life sciences and digital health sectors. As companies navigate the evolving regulatory landscape, understanding the implications of this legislative framework becomes essential

Are Pharmacy Benefit Managers Behind Soaring Insulin Prices?
Regulatory & Compliance Are Pharmacy Benefit Managers Behind Soaring Insulin Prices?

The cost of insulin has surged dramatically over the past decades, burdening patients who rely on this life-saving medication. Rising costs have drawn scrutiny from regulators, lawmakers, and consumers, leading to investigations into the pharmaceutical industry's pricing mechanisms. Among the

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