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 […]
5 fast tips to make medical device clinical trials faster and cheaper
1. Keep your design simple. More then 100 parameters per subject is too much. 2. Plan your time. Start 6 months before first patient in. Plan to do a little bit every day. 3. Use eSource. Type the data directly into the EDC or into a tablet that inserts to the EDC 4. Ban SDV. […]
Why your security is worse than you think
Thoughts for Yom Kippur – the Jewish day of atonement – coming up next Wed. Security on modern operating systems (Windows, OS/X, iOS, Android, Linux) is getting better all the time – but Android using SELinux and MAC (mandatory access control) doesn’t make for catchy, social-media-sticky news items. A client (a good one) once told […]
14 years after 9/11, more connected, more social, more violent
Friday, today is the 14’th anniversary of the Al Queda attack on the US in New York on 9/11/2001. The world today is more connected, more always-on, more accessible…and more hostile. There are threats from Islamic terror, identity theft, hacking for pay, custom spyware, mobile malware, money laundering and corporate espionage. For those of us […]
The importance of risk analysis for HIPAA compliance
A chain of risk analysis The HIPAA Final Rule creates a chain of risk analysis and compliance from the hospital, downstream to the business associates who handle / process PHI for the hospital and sub-contractors who handle / process PHI for the business associate. And so on. The first thing an organization needs to do is a risk analysis. […]
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 […]
Dealing with DLP and privacy
Dealing with DLP and privacy It’s a long hot summer here in the Middle East and with 2/3 of the office out on vacation, you have some time to reflect on data security. Or on the humidity. Or on a cold beer. Maybe you are working on building a business case for DLP technology like Websense or Symantec or Verdasys, or Mcafee or Fidelis in […]
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. […]
10 ways to detect employees who are a threat to PHI
Software Associates specializes in software security and privacy compliance for medical device vendors in Israel. One of the great things about working with Israeli medical device vendors is the level of innovation, drive and abundance of smart people. It’s why I get up in the morning. Most people who don’t work in security, assume […]
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 […]
