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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

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