DUBLIN--(BUSINESS WIRE)--The "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" conference has been added to ResearchAndMarkets.com's offering.
The 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 premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, and the explosion in the use of wireless communication and mobile apps.
Inadequate cybersecurity programs and the lack of interoperability for healthcare users pose the greatest threat to any healthcare system. Software exploitations are using more sophisticated approaches and the hackers' programs are readily available on the "dark web."
The increasing sophistication required to protect software programs and have them work with other programs requires progressive software design and software validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. FDA can ask you what you have considered before you take a product to market. Whether your software can survive unscathed is another question.
Why You Should Attend:
For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for premarket review and performance criteria evaluation.
The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight of cybersecurity management.
Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability problems surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?
These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.
Topics:
- FDA's risk-based regulatory strategy
- Cybersecurity
- Interoperability
- National Institute of Standards and Technology
- Voluntary standards and programs
- Mobile Apps
- Premarket software validation and design requirements
- Postmarket Software recalls
Who Should Attend:
- Regulatory Affairs
- Quality Assurance
- Software Design Engineers
- Manufacturing
- Complaint Dept.
- Hospital Risk Dept.
-
Own label marketers
For more information about this conference visit https://www.researchandmarkets.com/research/tkmxw4/fdas_software?w=4
