Why paper should be your first choice for a medical device clinical trial
6 reasons to use paper in your clinical trial You’ve been considering cloud EDC for your next clinical trial, but you are put off by the perceived challenges and costs of implementation and operation. You shudder at the thought of DIY EDC solutions like Clincapture or Medrio and don’t have the budget for Medidata. For many […]
5 ways to reduce costs and accelerate medical device clinical trials
Time is money The economic model of a multi-center clinical trial is based on a commercial biotech/biomed/pharma company sponsoring and funding clinical research in order to prove efficacy and or safety of a new drug or medical device. In fact, although the sponsor has the most at stake by far, in clinical trials, sponsors and […]
The chasm between FDA regulatory and cyber security
When a Risk Analysis is not a Risk analysis Superficially at least, there is not a lot of difference between a threat analysis that is part of a software/hardware security assessment and a risk analysis (or hazard analysis) that is performed by a medical device company as part of their submission to the FDA. […]
2 mistakes you do not want to make in your medical device clinical trial
Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children – […]
How do you know that your personal health data is secure in the cloud?
Modern system architecture for medical devices is a triangle of Medical device, Mobile app and Cloud services (storing, processing and visualizing health data collected from the device). This creates the need for verifying a chain of trust: patient, medical device, mobile app software, distributed interfaces, cloud service software, cloud service provider. No get out of jail free card if […]
You can DIY a chair from IKEA. You cannot DIY your medical device clinical trial
Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children […]
The top 5 things a medical device vendor should do for HIPAA compliance
We specialize in software security assessments, FDA cyber-security and HIPAA compliance for medical device vendors in Israel. The first question that every medical device vendor CEO asks us is “What is the fastest and cheapest way for us to be HIPAA-compliant”? So here are the top 5 things a medical device vendor should do in order to […]
Health Information Technology Patient Safety Action & Surveillance Plan
This is a quick update on two new documents released by the HHS and the IMDRF: Health Information Technology Patient Safety Action & Surveillance Plan The US Department of Health and Human Services published on July 2, 2013 the Health Information Technology Patient Safety Action & Surveillance Plan. The FDA belongs to the HHS. The plan defines several […]
Risk assessment for your medical device
We specialize in cyber-security and privacy compliance for medical device vendors in Israel like you. We’ve assissted dozens of Israeli software medical device that use Web, mobile, cloud and hospital IT networks achieve cost-effective HIPAA compliance and meet FDA guidance on Premarket Submissions for Management of Cybersecurity in Medical Devices. As part of our service to our trusted clients, we provide the popular PTA threat modeling tool, […]
Why Microsoft Windows is a bad idea for medical devices
I’m getting some push back on LinkedIn on my articles on banning Microsoft Windows from medical devices that are installed in hospitals – read more about why Windows is a bad idea for medical devices here and here. Scott Caldwell tells us that the FDA doesn’t rule “out” or “in” any particular technology, including Windows […]
