FDA and New Cybersecurity Regulations

A friend forwarded this post to me.

Links worth checking out…

Here are my thoughts…

  • Frankly, security in healthcare devices ranges from embarrassing to terrifying—especially at the interface point between devices/systems. As more devices become network enabled, the level of risk is exponentially increased. Too often, software in medical devices are built by clinically focused developers, or hardware engineers tasked also with the software layer. Developing for security (and performance) is a specific skill set within software development, and it is not commonly found in the average developer. I have found that developers with experience in Web-based consumer applications (that manage personal data) and those with banking application experience generally “get it” more than others, but that’s just my experience. Also, product managers need to get a lot smarter about security and make it a priority in the product scope.
  • Regulations are brought in when industry fails to protect the public interest, and that is what is happening here. If the medical device industry was better at doing proper risk-based design and validation—which security and protection of data would certainly be an area of focus—and including risk mitigation controls in their designs, the FDA would not need to issue regulations. But, here we are. Now we get to see if government regulators can produce effective regulations, and keep pace with the ever-evolving security model best practices and methods.
  • Where the HIPAA Security and Privacy rule applies to the healthcare provider organization (that is, it is their responsibility), FDA regulations apply to the registered device manufacturer. Regulatory Affairs staff working for the vendor community are going to have to learn a lot more about cybersecurity. Most of the professionals in this field that I know, know very little about this topic. If you are a cybersecurity consultant that knows even a little about healthcare IT application design patterns and existing medical device regulations, this is a goldmine. Hmmm, maybe I will study this FDA stuff in more detail. 🙂

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