Software’s level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars. Life supporting and life sustaining health grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice.
FDA looks at software in one of three ways: standalone, such as for a mobile app; device-based software used to control a device’s performance; or simply electronic records. FDA’s risk classification will gradually clarify how it intends to manage the health risks with new premarket controls and postmarket options. The FDA did not foresee the cancer of cybersecurity attacks, interoperability failures, the massive use of wireless communication, and mobile apps.
Location: Dallas, TX
Venue: To Be Decided
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.
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