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FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017

Start Date:
Thursday, 7 September, 2017
End Date:
Friday, 8 September, 2017 4:30pm
Nephrology, Gastroenterology, Immunology, Pain Management, Psychiatry, Hepatology, Cardiology, Endocrinology

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars.

Life supporting and life sustaining healthcare 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.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. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system.

In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems, preventing them from recurring. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful of the unknowns that lurk in the future of software regulated as a device by the FDA. 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 strategyCybersecurityInteroperabilityNational Institute of Standards and TechnologyVoluntary standards and programsMobile AppsPremarket software validation and design requirementsPostmarket Software recalls Who Will Benefit: Regulatory AffairsQuality AssuranceSoftware Design EngineersManufacturingComplaint Dept.Hospital Risk Dept.Own label marketers Agenda: Day 1 Schedule 9:00 am - 10:15 amLecture 1: FDA authority and regulatory programTypes of Software are devicesRegulatory strategyRisk classificationOffice of the National Coordinator (ONC) for Health Information ProtectionSoftware regulatory applicationsFDA GuidancePremarket submissionsParadigms: aeronautics10:15am - 10:30am Break10:30 am - 12:00 amQuality System Regulation (QSR)Design verification and validationVoluntary standardsCorrective and Prevent Action PlansVoluntary standardsRecalls:Service / maintenance / recall.Implementation strategyCorrections and Removals reportingUpdates: FDA vs. non-FDAPredictive analytics12:00 PM - 1:00 PM Lunch1:00 PM - 2:30 PMLecture 2: InteroperabilityCompatibility by designHardwareSoftwareLabelingPrecautionsInstructions for useUse of Voluntary Standards2:30 PM - 2:45 PM Break2:45 PM - 4:15 PMProprietary informationFailure management / follow upUser's vs. manufacturer's legal responsibilitySystem configurationCustomizationEnvironment of useProfessionalDay 2 Schedule9:00 am - 10:15 amLecture 1: CybersecurityDevice vulnerabilities: malfunction and failurePre-emptive design and evolutionHackers' malware/virus strategy10:30 am - 10:45 am Break10:45 am - 12:00 pmPost-event managementCorrective and preventive action for softwareDisclosure to usersReports to the FDA waiverNational Institute of Standards and Technology Reports12:00 PM - 1:00 PM Lunch1:00 PM - 2:30 PMLecture 2: Medical Mobile Applications (mobile apps)Mobile apps defined as a deviceFDA regulatory strategy and guidanceNational Institute of Science and Technology Report and CollaborationUpdates (FDA vs. non-FDA updates)Criteria for corrective and preventive action deemed recallsReports of Corrections and RemovalsReports of adverse events2:30 PM - 2:45 PM Break2:45 PM - 4:30 PMLecture 3: Professional vs. lay use / home useLabeling: instructions for use and precautionsEnvironment of useFDA regulation of accessoriesFederal Communications Commission (FCC) regulation SpeakerCasper Uldriksex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks brings over 32 years of experience from the FDA.

He specializes 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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value.

He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters. Location: SFO, CA Date: September 7th & 8th, 2017 and Time: 9:00 AM to 4:30 PM Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010 Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until July 20, Early Bird Price: $1,295.00 From July 21 to September 05, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}



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Conference organized by NetZealous DBA as GlobalCompliancePanel

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