ARTICLE
16 February 2026

Regulatory Horizons: Cybersecurity And FDA Regulated Companies (Podcast)

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BakerHostetler

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Recognized as one of the top firms for client service, BakerHostetler is a leading national law firm that helps clients around the world address their most complex and critical business and regulatory issues. With five core national practice groups — Business, Labor and Employment, Intellectual Property, Litigation, and Tax — the firm has more than 970 lawyers located in 14 offices coast to coast. BakerHostetler is widely regarded as having one of the country’s top 10 tax practices, a nationally recognized litigation practice, an award-winning data privacy practice and an industry-leading business practice. The firm is also recognized internationally for its groundbreaking work recovering more than $13 billion in the Madoff Recovery Initiative, representing the SIPA Trustee for the liquidation of Bernard L. Madoff Investment Securities LLC. Visit bakerlaw.com
Cybersecurity is no longer just an IT or privacy issue. For FDA regulated companies, it's a patient safety issue, a product quality issue, and increasingly a regulatory enforcement issue.
United States Food, Drugs, Healthcare, Life Sciences
Winston S. Kirton’s articles from BakerHostetler are most popular:
  • within Food, Drugs, Healthcare and Life Sciences topic(s)
  • in United States
  • with readers working within the Healthcare industries

Cybersecurity is no longer just an IT or privacy issue. For FDA regulated companies, it's a patient safety issue, a product quality issue, and increasingly a regulatory enforcement issue. FDA has made it clear that cybersecurity vulnerabilities can affect medical devices, software, manufacturing operations, clinical data, and even the availability of life saving products.

Today, we're bringing together two perspectives—the FDA regulatory lens and the cybersecurity lens—to talk about what companies need to understand and where they're getting tripped up.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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