If the acronym “AI” makes you immediately think of a sci-fi movie, you’re not alone! Some of us have even humbly acknowledged that the topic of AI—Artificial Intelligence—seems daunting and hard to relate to our legal practice. Whether you fall on one end of the AI spectrum (“what the heck is AI?”) or the other (“what are the hot trends in AI?”), this issue of Pro Te is for you. In this issue, we tackle the ever-advancing role of AI on the law and, more specifically, the impact of AI on the pharmaceutical industry. As you’ll see below—and as we hope you’ll read with interest—AI has definite upsides, but it also poses real risks.
In Cybersecurity Threats in Healthcare, we explore how AI has opened our eyes to new threats in the healthcare industry: from software hacking to medical device vulnerabilities and ransoming of hacked information, there is no question but that the use of AI presents risks. Given that such threats are a concern for healthcare providers, hospitals and device manufacturers, we share some insight, and provide an overview of the FDA’s guidance on these trending issues.
In Dr. A.I.: The Evolution of the Use and Regulation of Artificial Intelligence in Medical Practice and Drug Development, we discuss the positive benefits of AI. These include the ability to gather information necessary for advanced drug and device development through AI—as well as the role of AI in improvement of patient diagnoses and evaluation of possible treatments.
Finally, in Using Artificial Intelligence in Drug Discovery, we discuss not only the role of AI in analyzing and processing large volumes of data, but also how AI enabled collaborations may create licensing and intellectual property issues. These are items you may want to consider when crafting the agreements that govern such arrangements, and we hope you’ll find the insight useful.