Ivor Campbell, CEO of Snedden Campbell
The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change.
The confluence of geopolitical tensions, economic uncertainty, and evolving social values has created…
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Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable…
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When Tesla’s first electric car models hit the market in 2012, the company rolled out a national network of hundreds of charging sites within a few months. Today, they’ve expanded to thousands of charging…
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Join the Assistant Secretary for Financial Resources (ASFR) and the Assistant Secretary for Technology Policy for an overview of ASFR’s proposed rule, the HHS Acquisition Regulation: Acquisition of Information Technology; Standards for Health Information…
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“The bottom line is that AI regulation is really about transparency. We don’t know everything.”
Those words were spoken by Luke Ralston — who has been a biomedical engineer and scientific reviewer at the FDA…
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Stricter regulation is inevitable, so how should MedTech companies respond? By Cognizant’s Rohit Alimchandani
The MedTech industry stands at a pivotal point, torn between fully embracing technological advancements, particularly in AI, and the demands of…
Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis…
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The U.S. Department of Health and Human Services issued a new proposed rule earlier this month outlining new standards and requirements around acquisition of health information technology.As described in the proposal, which was published…
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The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the…
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Andy Molnar, CEO of the Digital Therapeutics Alliance, has been selected as an industry representative for the FDA’s Digital Health Advisory Committee (DHAC). The FDA established the DHAC to ensure safe and effective regulation of…
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