FDAs Current Change in Software Regulation and Future Cybersecurity Concerns for Digital Health Functions

Casper Uldriks

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Background: 

Congress saw that FDA struggles to regulate software.  So, Congress removed some software from FDA’s jurisdiction.  The FDA must now revise its premarket and postmarket regulatory, including mobile apps.  Using voluntary standards in premarket submissions will make the process more efficient and effective.  Even more dramatic, FDA’s new Digital Health Initiative assigns FDA’s premarket clearance determinations to software manufacturers. Moving forward, cybersecurity development and management for FDA’s Digital Health program is not well defined, which leads Digital Health technology quite vulnerable for new reasons.  The approach places trust and quality at the core of the process.  Overall, the burden of software regulation for industry and the FDA has eased up. Those changes will save time and money for everyone involved.

Why attendees should register:

·         Software manufacturers should identify what software is no longer regulated and why. 

·         If a firm wants to clear its software for marketing, understanding the qualifications and terms of participation is necessary.

·         If a firm suffers a cybersecurity intrusion, you may not be required to submit a recall report.  There are benefits and risks to your options.

You need to update your regulatory program to create a cybersecurity strategy for Digital Health software which creates new concerns going forward

Description of the topic: 


The webinar covers changes in FDA’s regulatory program for software.  The changes, were in part, initiated under the mandate of the 21st Century Cures Act.  Congress and FDA recognize that the evolution of software grows faster than FDA is capable of understanding and managing.  Some of their regulatory oversight has been rescinded by Congress.  FDA is relying more on the use of voluntary standards and the guidance provided by the National Institute of Health.  This is especially true for issues concerning cybersecurity and software interoperability.  FDA’s regulation of software will likely keep changing as software technology advances.  One such example is cybersecurity management of Digital Health program functions.

Areas Covered in the Webinar Session:

·         21st Century Cures Act impact

·         Software that is no longer regulated by FDA

·         Changes in premarket requirements

·         Voluntary controls as a premarket shortcut

·         Postmarket reporting options

Digital Health Initiative – FDA clearance not required and new cybersecurity expections

     Who will benefit: 

  •  Healthcare institutions – electronic healthcare records managers (EHR)
  •  Clinical  application users, such as mobile treatment programs
  •  Medical device manufacturers
  •    Regulatory affairs directors
  •  Software design engineers

Target Association/Societies:

Regulatory Affairs Profession (RAPS)

AdvaMed (medical device manufactures)

Medical Device Manufacturers Association (MDMA)

The Association of Electrical Equipment and Medical Imaging Manufacturers (NEMA)

Target Audience to market:

 Regulatory affairs directors

 Software designers/specification developers

 Production managers

Quality assurance directors

In-house legal counsel

Marketing directors

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Casper Uldriks,

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 Radio-logical 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.


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