What risks really count for your clinical trials?
Is there a “black-box” risk management solution for your clinical trial? What clinical trial risks are the most important for you and your company? Risk mitigation and risk management for your clinical trials What clinical trial risks really count for your company? No question is more important for implementing an effective program of risk-mitigation and […]
How understanding culture reduces risk in your clinical trials
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 […]
3 things a medical device vendor must do for security incident response
You are VP R&D or CEO or regulatory and compliance officer at a medical device company. Your medical devices measure something (blood sugar, urine analysis, facial anomalies, you name it…). The medical device interfaces to a mobile app that provides a User Interface and transfers patient data to a cloud application using RESTful services over HTTPS. Sound familiar? […]
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 […]
The best cybersecurity strategy may be counter-terror
Danny Lieberman suggests that a demand-side strategy with peer-review may work best for cyber-security. A conventional military paradigm does not work for cyber-security Government cyber security policy, molded by the military; traditionally frames cyber-security in the context of a defensive strategy based on intelligence gathering, threat analysis, modeling and monitoring with deployment of defensive network […]
The valley of death between IT and information security
IT is about executing predictable business processes. Security is about reducing the impact of unpredictable attacks to a your organization. In order ot bridge the chasm – IT and security need to adopt a common goal and a common language – a language of customer-centric threat modelling Typically, when a company ( business unit, department or […]
Ten steps to protecting your organization’s data
Here are 10 steps to protecting your organization’s privacy data and intellectual property. As a preface, begin with the understanding that you already have all the resources you need. Discussions with colleagues in a large forensics accounting firm that specialize in anti-fraud investigations, money laundering and anti-terror funding (ATF), confirm what I’ve suspected for a […]
Security and the theory of constraints
Security management is tricky. It’s not only about technical controls and good software development practice. It’s also about management responsibility. If you remember TOC ( Theory of Constraints, invented by Dr. Eli Goldratt about 40 years ago) there is only 1 key constraint that limits system (or company) performance to achieve it’s goal. So – what […]
The Tao of GRC
I have heard of military operations that were clumsy but swift, but I have never seen one that was skillful and lasted a long time. Master Sun (Chapter 2 – Doing Battle, the Art of War). The GRC (governance, risk and compliance) market is driven by three factors: government regulation such as Sarbanes-Oxley, industry compliance […]
