How understanding culture reduces risk in your clinical trials

GCP risk

It’s during the war the Russians are waging on Ukraine and I got on a thread on a blog about why Putin is so violent. I replied that from Putin’s perspective – the US and Europeans represented an existential threat to him when they pull Ukraine into NATO and when the US pushes democracy eastwards. […]

A word to Teva on firing employees and assuring data security

To be able to do something before it exists, sense before it becomes active, and see before it sprouts. The Book of Balance and Harmony (Chung-ho chi). A medieval Taoist book In early December 2017, the Israeli pharmaceutical generics company Teva announced it would lay off about 1,700 of its employees in Israel, who make up […]

Kick start your European privacy compliance

The CNIL’s Sanctions Committee issues a 150 000 € monetary penalty to GOOGLE Inc. On 3 January 2014, the CNIL’s Sanctions Committee issued a 150 000 € monetary penalty to GOOGLE Inc. upon considering that the privacy policy implemented since 1 March 2012 does not comply with the French Data Protection Act. It ordered the company […]

4 steps to small business security

Software Associates specializes in security and compliance for biomed.  Many of our biomed clients are small 3-10 person startups working out of a small office and not having neither the IT budget nor the IT best practices to take care of their own network. According to the latest statistics from the FBI in their annual […]

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 […]

Treat passwords like cash

How much personal technology do you carry around when you travel?  Do you use one of those carry-on bags with your notebook computer on top of the carry-on? A friend who is a commercial pilot had his bag swiped literally behind his back while waiting on line to check-in to a 4 star Paris hotel. […]

Tahrir square – the high-tech version

From Wired The revolt that started a year ago today in Egypt was spread by Twitter and YouTube, or so the popular conception goes. But a group of Navy-backed researchers has a more controversial thesis:Egyptians were infected by the idea of overthrowing their dictator. Using epidemiological modeling to chart the discussions and their trajectory online is an interesting idea, I don’t […]

How to reduce risk of a data breach

Historical data in  log files  has little intrinsic value in the here-and-now process of event response and mediation and compliance check lists have little direct value in protecting customers. Software Associates specializes in helping medical device and healthcare vendors achieve HIPAA compliance and improve the data and software security of their products in hospital and […]

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, […]

Risk analysis of legacy systems

A practical, proven methodology for practical risk assessment and security breach risk reduction in enterprise software systems. Click here to download the article