Crossing the valley of death of clinical trial monitoring
When hype exceeds adoption As a matter of fact, hype always succeeds adoption and rightly so – because hype is a way of getting our attention and getting us to try out a new product or service. But how can we discern substance from online marketing content? As a new hire at Intel, I wrote weekly progress […]
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 […]
On Shoshin and Software Security
I am an independent software security consultant specializing in medical device security and HIPAA compliance in Israel. I use the state-of-the art PTA – Practical Threat Analysis tool to perform quantitative threat analysis and produce a bespoke, cost-effective security portfolio for my customers that fits their medical device technology. There are over 700 medical device companies […]
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). […]
The death of the anti-virus
Does anti-virus really protect your data? Additional security controls do not necessarily reduce risk. Installing more security products is never a free lunch and tends to increase the total system risk and cost of ownership, as a result of the interaction between the elements. We use the quantitative threat analysis tool – PTA that enables […]
Why anti-virus doesn’t work for medical devices
Are you checking off medical device security in your hospital with anti-virus: falling for security theater; feeling secure and enjoying the show, but in fact being less secure? A medical device is not an office PC The most commong security countermeasure in use today is anti-virus software for Windows-based workstations to protect the Windows PC from […]
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 […]
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 […]
Is your HIPAA security like a washing machine?
Is your HIPAA security management like a washing machine? Most security appliance vendors use fluffy charts with a 4 step “information risk management” cycle. It’s always a 4 step cycle, like “Discover, Monitor, Protect and Manage” and it’s usually on a circular chart but sometimes in a Gartner-style magic quadrant or on a line. It’s […]
How to use BI to improve healthcare IT security
Information technology management is about executing predictable business processes. Information Security Management is about reducing the impact of unpredictable attacks to your healthcare provider organization. Once we put it this way – it’s clear that IT and security and compliance professionals, as dedicated as they are to their particular missions – do not have common […]
