Law360 Runs Nate Brown, Marlee Gallant Analysis on Cloud-Services in Life Sciences

“Life Sciences Regulators Must Write Cloud-Specific Guidance,” an article by Akin health care & life sciences partner Nate Brown and counsel Marlee Gallant, has been published by Law360. The article looks at cloud services and the ways in which the life sciences industry uses them extensively.

They write, “As one of the most highly regulated industries, compliance systems, including maintenance of records, are critical to life sciences entities and entities in this space are increasingly looking to cloud services to support their regulated activities.”

However, they note, “Although the U.S. Food and Drug Administration and other government bodies have indicated support for the use of cloud services, and many of them leverage the cloud themselves, some government written policies are out of date or otherwise create confusion about cloud use.”

The authors note that the FDA and other agencies recognize the advantages of the cloud in large-volume data management, even as regulations and guidance are inconsistent and confusing with regard to cloud policy. To address what they consider an “ambiguous” policy approach, they write, “The FDA should issue a policy statement to: (1) make clear that entities may use the cloud to support compliance activities throughout the product lifecycle, not just documents related to clinical trials; and (2) address nuances specific to the cloud, such as that a precise physical location does not need to be on premises or even known to the regulated entity.”

They also note that this clarity is necessary on a global scale, and that a clear position from the FDA would sent a strong signal to other governments, whose own lack of standardization and uniformity regarding regulations decreases “entities’ agility and capacity to innovate.”

The authors close by noting that regulators should issue coordinated, clear policy on the cloud to encourage uptake, suggesting four steps that FDA can take to improve clarity and confidence, noting, “These steps would mark significant progress toward the FDA's goal to advance the use of the cloud and allow life sciences entities to move forward with their use of the cloud with confidence, enabling secure and efficient support for regulated activities.”

To read the full article, click here.