#16: It is a best practice to initiate a constructive dialogue with FDA experts early in the process, and incorporate their advice and questions in the building of the submission. Pre-Submission meetings are ideal opportunities to discuss prospective regulatory plans.
#17: Timely and effective communications will help execute a successful submission.
#18: The focus of HIPAA-HITECH is to protect PHI “Protected Health Information”. There are 18 PHI identifiers.
#19: There are six steps to gain HIPAA-HITECH compliance:
- Perform a security Risk Assessment
- Establish a Quality Process and Procedures
- Establish a Software Development Process
- Deploy HIPAA-HITECH training
- Craft your own Business Associate Agreement
#20: The largest 125 U.S. health Insurers (out of a total of 12,000 players) collected $744 Billion in premiums, or 50% more than the global MedTech market forecasted for 2020. This is a huge industry. Do not assume you can deal with it without significant planning and effort.