Preventing patient data leaks
6 ways to protect patient data in your eClinical and digital health applications Patient data leaks is much more than patient privacy. Patient data leaks require a more complete approach to threat mitigation of patient data leakage, availability and data integrity attacks. Since 2019, we see rapidly increased use of decentralized clinical trials, hybrid trials, […]
How to meet the 10 top challenges in Phase 1 clinical trials
Phase 1 challenges are unlike larger Phase 2, Phase 3 studies. The science is still unsure. The the clinical operations team at a startup may still be under construction. In this post, I’ll share our experiences at flaskdata.io with early stage drug and device vendors doing their first Phase 1 safety study. You’ll see a […]
Clinical data management, payment for outcomes
Payment for outcomes using GCP metrics is a way to significantly reduce clinical operations costs and increase value-for-money from your CRO or DCT vendor. Payment for outcomes using GCP metrics shifts study costs from billable activities to measurable results. Professional service activities are hard to control. GCP metrics are hard to contest. In this post, […]
Patient compliance in clinical trials – the elephant in the room
Clinical trials cost a fortune. When a patient is non-compliant during the run-in/washout period, he/she is dropped out of the study. This costs the sponsor 5X: site costs for 2 patients, recruitment costs for 2 patients and loss of time. In other words, retention is more important than recruitment. This raises the question: why is […]
3 ways that assure protocol compliance and data integrity in your clinical trials
In this short essay, I’ll take a closer look at how the clinical trial supply chain is evolving. There is now rapid change from traditional site-centric trials to patient-centric operations that assure data integrity and safety monitoring We’ll see how the pandemic, innovation in clinical operations models and consumer technology drive the change to patient-centric research. […]
3 things to do before you spend money on a HIPAA consultant for your clinical trial
Flaskdata specializes in same data data and safety solutions for clinical trials. Flaskdata is a technology company specializing in clinical datamanagement and monitoring. We are accomplished at providing our customers with the most effective way to achieve high quality clinical dataand assure patient safety. There is no single solution that works for everyclinical trial. We work […]
Why HIPAA Policies and Procedures are not copy and paste
Compliance from Dr. Google is a very bad idea. Searching for HIPAA Security Rule compliance yields about 1.8Million hits on Google. Some of the information is outdated and does not relate to the Final Rule and a good deal of other information is sponsored by service providers and technology companies selling silver bullets for HIPAA compliance. The […]
The chasm between FDA regulatory and cyber security
When a Risk Analysis is not a Risk analysis Superficially at least, there is not a lot of difference between a threat analysis that is part of a software/hardware security assessment and a risk analysis (or hazard analysis) that is performed by a medical device company as part of their submission to the FDA. […]
PCI DSS is a standard for the card associations not for your business
I recently saw a post from a blog on a corporate web site from a company called Cloud compliance, entitled “Compliance is the New Security Standard“. Cloud Compliance provides a SaaS-based identity and Access Assessment (IdAA) solution that helps identify and remediate access control and entitlement policy violations. We combine the economies of cloud […]
Risk does not walk alone
Israeli biomed companies often ask us about the roles of audit and risk management in their HIPAA security and compliance activities. At the eHealth conference in Israel last week – a lawyer gave a presentation on HIPAA compliance and stated: If you have to do one thing, make sure everything is documented – your policies […]
