Renewed Focus on Cybersecurity May Have Significant Impacts on Previously Shielded Healthcare Companies

Following President Biden's cybersecurity executive order, the FDA issued the Response to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain Security on May 26, 2021, which acknowledges that “cybersecurity is crucial for medical device safety and effectiveness.” However, it is important to recognize that currently, the FDA’s ability to regulate cybersecurity extends only to medical devices.