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Event Details


FDA's Problem with Software Monsters

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Who should attend?

Business Planning Executives Regulatory Directors Software Design and Specification Developers Real time Software Performance Auditors Recall Managers In-house Legal Counsel Customer Support and Service Directors Contract Specialists Business Acquisition Managers Hospital Risk Managers



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 software 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 based on the risk to health associated with the software's use.

Cybersecurity problems for software for life sustain devices, wireless networks for patient manage and home use devices open the gate for cyber intrusion, functional malware and total denial of access denial to an entire network of software, such as that used in hospitals and clinics. Who will help you? This becomes a self-help scenario; FDA and the FBI cannot protect you from the "bad guy." An equally disastrous problem involves interoperability failures.

If your software does not cross the bridge of software communication, that software becomes worthless. Wireless technology, mobile apps and home use of software-based devices raise endless vulnerabilities. How you protect yourself and your customers in this swamp of disasters is critical.

Why should you Attend

FDA's regulatory controls

Cybersecurity management

Ransomware attacks and recovery

Use voluntary standards and NIST

Mobile apps

Wireless/home use software systems

Areas Covered in the Session

Understand FDA's risk-based regulatory strategy

Learn where FDA and you can find current technical help

Highlight the problems of interoperability and what you can do about it

Familiarize yourself with the National Institute of Standards and Technology's (NIST) role in cybersecurity prevention and interoperability considerations

Learn about the FDA's increased use of voluntary standards

Clarify FDA's ongoing revision of mobile app regulation




Joseph Wilcox

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