Category: Compliance

  • The golden rules of HIPAA compliance for your clinical trials

    As Flask Data customers progress through their clinical trial journey to FDA clearance and post-marketing, we are frequently asked on how to achieve HIPAA compliance in an era of digital health apps, medical IoT and collection of RWD (real-world data) from patients. I will try and help you make sense out of HIPAA and the HITECH […]

  • 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 Some of  the information is outdated and does not relate to the Final Rule and a good deal of other information is sponsored by service providers and technology companies selling silver bullets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 […]

  • 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? […]

  • Refreshing your HIPAA Security Rule compliance

    Clients frequently ask us questions like this. Danny, I have a quick question about our HIPAA compliance that we achieved back in early 2013. Since then  we have released a couple of new software versions and we are wondering to what extent we need to perform another security and compliance assessment.  Please let us know what sort of information you might […]

  • Privacy, Security, HIPAA and you.

    Medical devices, mobile apps, Web applications – storing data in the cloud, sharing with hospitals and doctors. How do I comply with HIPAA? What applies to me – the Security Rule, the Privacy Rule or both? Consider a common use case these days – you’re a medical device vendor and your device stores health information in the cloud. […]

  • 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 […]

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