The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the 'healthcare software' dialogue.
What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology. Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.
Why you should attend
Who Will Benefit
What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology. Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.
Why you should attend
- FDA's changing regulatory controls
- Cybersecurity management by design, oversight and preventive action
- Ransomware attacks and recovery
- Use voluntary standards and NIST
- Mobile apps regulated and those not regulated
- Wireless/home use software systems and human factors
Who Will Benefit
- 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
Agenda
- Understand FDA's regulatory program
- Identify Cybersecurity Operations
- Vulnerabilities
- Pre and post event management
- Integrate the expanding use of voluntary standards
- Identify business and regulatory problems
- Hardware and software integration
- Labeling and disclosure
- Failure management
- Explain the legally required de-regulation of mobile apps
- Identify vulnerabilities of using wireless technology and home use
Speaker
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 Radiological 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. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.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
