How to overcome 5 eSource implementation challenges
Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro. Frankly, its easier to talk about change for other people than for yourself. A lot easier. I have written here, here and here […]
Cost effective EDC for medical device clinical trials
There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt […]
The key is not first to eSource, the key is smart to market
This post is not for the Pfizers, Novartis, Merck and GSK giants of the life science industry. Its for the innovators, the smaller, creative life science companies that are challenged by the costs, the regulatory load and complexity of executing a clinical trial. This post is dedicated to the startup entrepreneurs of the world. Building an EDC […]
An attack modeling approach to medical device clinical trials
What does taking off your shoes and belt in the airport have in common with risk assessment in clinical trials? Today we talk about the drawbacks of traditional risk assessment and propose an alternative approach to clinical trial risk assessment that is based on data and considering plausible attacks on your trial as opposed to fixed protocols and […]
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 […]
What is PHI?
Software Associates specialize in HIPAA security and compliance for Israeli medical device companies – and 2 questions always come up: “What is PHI?” and “What is electronically protected health information?” Of course, you will have already Googled this problem and come to one conclusion or another by surfing sites like Hipaa Compliance Made Easy or the Wikipedia entry on HIPAA. […]
Shock therapy for medical device malware
Israel has over 700 medical device vendors. Sometimes it seems like half of them are attaching to the cloud and the other are developing mobile apps for all kinds of crazy, innovative applications like Healthy.io ( Visual Input Turned Into Powerful Medical Insight – translation: an app that lets you do urine analysis using your smart phone). […]
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 […]
Why security defenses are a mistake
Security defenses don’t improve our understanding of the root causes of data breaches Why is this so? Because when you defend against a data breach – you do not necessarily understand the vulnerabilities that can be exploited. If do not understand the root causes of your vulnerabilities, how can you justify and measure the effectiveness of […]
Software in Medical Devices – Update
We have previously written about various aspects of the software development process, especially, the verification and validation activities in implanted and invasive medical devices. Here is an update on what is happening in the regulatory arena and how the regulatory groups are checking up on what we are doing. Software Recalls 2012 The estimate for software recalls […]
