6-Hour Virtual Seminar on FDA's Software Monsters

[John Robinson]

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.

• 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 are the people get benifits with this

• 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