Preventing drug counterfeiting
Counterfeiting is old as money itself. Drug counterfeiting is no exception. In this post, we’ll share an analytical approach that you can use to estimate the risk of drug counterfeiting to your drug products. Why are Medicines a Target for counterfeiting? Pharma is a highly regulated sector. Why do drugs attract counterfeiters? Fakes can be […]
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 […]
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 […]
Clinical trials in the cloud
Ben Baumann from Akaza and Open Clinica fame, recently blogged about clinical trials in the cloud. Ben is pitching the relatively new offering from Akaza called Open Clinica Optimized hosting that offers quick startup using validated Open Clinica instances and resources on-demand on a SAS-70 compliant platform. As Ben noted that in the clinical research field, […]
Catch 22 and Compliance
Let’s say your’e a payment processor going through a PCI DSS 2.0 audit: Does this sound familiar? (just replace certain words by certain other compliance related words): Without realizing how it had come about, the combat men in the squadron discovered themselves dominated by the administrators appointed to serve them. They were bullied, insulted, harassed […]
Why your IT vendor doesn’t want you to do a risk analysis
Did you ever have a feeling that your IT integrator was treating you like a couple of guys selling you a Persian rug? “Take it now – it’s so beautfiful, just perfect for your living room, a steal for only $10,000 and it’s on sale” and when you ask if it will last, they tell […]
Threats on personal health information
A recent HIPAA violation in Canada where an imaging technician accessed the medical records of her ex-husband’s girlfriend comes as no surprise to me. Data leakage of ePHI in hospitals is rampant simply because a) there is a lot of it floating around and b) because of human nature. Humans being naturally curious, sometimes vindictive and always […]
Paying the price for peace
An exceptional post by Lilac Sigan “To bad it doesn’t pay to be a nice guy” suggests that Israel may be better off in the long term with its relations with Turkey by demanding a quid-pro-quo (The Turks are demanding reparations and an official apology from Israel for boarding the now infamous Gaza flotilla boat […]
Health insurer data breaches
switched.com is having trouble understanding the attack vector of a data breach. They apparently believe that software vulnerabilities can be mitigated by consumers “actively protecting their information”. Hackers recently attacked WellPoint, a health insurer which reportedly covers 34 million people. As a result of the breach, the company notified 470,000 individual customers that confidential information, […]
Operational risk management – what we really need
Operational risk management has been the buzz word du-jour in recent years, due to the Basel II initiative in the banking industry and Solvency II in the insurance industry. The Basel II definition of operational risk is “the risk of loss resulting from inadequate or failed internal processes, people and systems, or from external events.” […]
