Threat modeling could be adapted into a process for developing medical AI with safety-by-design Medical AI developers need to create...

International regulators need and want to rely on each other's regulatory decisions for efficiency but don't want to lose sovereign...

How are you using GenAI for regulatory strategy, prep, submission, review, and response? GenAI, ChatGPT, LLMs, oh my! I am having a lot...

HSCC's new strategic plan is a valuable resource for anyone innovating, offering, or buying cybersecurity solutions for healthcare The...

Ease of use and usefulness are two strong predictors of adoption, but they're not enough in healthcare. Valuable innovations often go...

Entrepreneurs and innovators spend a lot of time pitching people on the value of their solution; that time can be deceptively wasteful...

The answer is always "it depends." The better question is: "Is this company managing product security well?" If I am a hospital system...

Health system procurement teams, rather than solely IT, hold the keys to solving healthcare cybersecurity. I recently met a tenacious...

Organizations change (if they don't they're dying). In the wake of a major reorg, here's how to thrive. FDA just announced that the...

The healthcare industry is plagued by problems that other industries have already solved. When solution providers try to help, they're...

People say "crawl, walk, run" to denote a progression of maturity to reach a goal. Institutions are not babies, and executives aren't...

Some people (ahem: me) tend to blow past a milestone without fanfare. Celebrating the milestones makes the innovation more delightful...

When your customers can't directly and immediately perceive the value of your product, you need to prove it I was in Vegas to see U2. As...

Definition of Risk: The potential for harm. Definition of Quality: A characteristic or attribute. Imagine you’re a seller of a software...

How to do enough security to survive and thrive through cybersecurity regulatory review and postmarket surveillance I attended the...

It used to be that product security experts needed to convince product developers that security was important to invest in, and that it...