Proposed LDT Rule and Patient Considerations
The LDT rule. I am going to keep this blog brief, because there are many posts on several media already, all with many thoughts and considerations. What I blog about today, is looking at it from patient perspective. As FDA points out in their proposed rule (PR), “an LDT to be an IVD that is […]
Digital Pathology is here to stay
Before start reading my blog, answer this question please:What drives patient management? Before providing my response to this question, let me start with sharing my statement, then with explaining the reasons behind my statement, providing my perspective response to the question and conclude with next steps. Statement:Digital pathology (DP) is here to stay.I am stating […]
…High on the agenda? Difficult? Important? Necessary?
… High on the agenda? Difficult? Important? Necessary? These are some examples of the unpublished words of the question “Why is interoperability so…?” of my previous blog. The answer to all these? Because it brings value to whom needs it! Yes, unfortunately it is also the answer to the question why interoperability is so difficult. […]
Why is interoperability so…?
Since I started in digital pathology in 2011, I noticed that interoperability has been on the agenda. It has always been prioritized because it is a high need to advance health care. And yet, here we are: still on the agenda, still being prioritized. Are we making progress? Today I would like to address interoperability […]
From Volume Based to Value Based Care
From volume based to value based care. This is what we hear. This is what we wish for our patients, this is what we want for our loved ones, for ourselves. Why then is it not happening? Today I am going to blog about reimbursement of diagnostic tests in the USA. I believe reimbursement can […]
FDA Pilot Program Lab Developed Companion Diagnostics
Today the FDA published a pilot program using minimal performance criteria for companion diagnostics. When reading it, I regard this could benefit patients and labs. FDA seems to be looking into no more one-drug-one test using minimal performance criteria. I certainly applaud this; it’s about care and well-being of patients. Reading the guidance, it seems […]
Grow Strong Through Teamship
ASCO, what a great conference (https://conferences.asco.org/am/attend). I am grateful to be among so many people working to fight against cancer. Can you imagine, what it would be like, when the collaboration in the pre-competitive space would grow stronger? I can. With this blog I want to take the opportunity to share that it’s no longer […]
When Following Your Inspiration Anything Is Possible
With my first blog on my own company’s website, I am sharing why I believe when following your aspiration anything is possible! These words sound too good to be true and usually when you read something that is too good to be true, it’s not. This is true. With today’s blog I am sharing my […]