Category: Risk management

  • Killed by code – back to the future

    I hope that the code in your digital therapeutic for treating autistic children, doesn’t look like this. Back in 2011, I thought it would only be a question of time before we have a drive by execution of a politician with an ICD (implanted cardiac device). In Jan 9, 2017 FDA reported in a FDA Safety […]

  • 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 […]

  • How do you know that your personal health data is secure in the cloud?

    Modern system architecture for medical devices is a triangle of Medical device, Mobile app and Cloud services (storing, processing and visualizing health data collected from the device).  This creates the need for verifying a chain of trust: patient, medical device, mobile app software, distributed interfaces, cloud service software, cloud service provider. No get out of jail free card if […]

  • What is PHI?

    Software Associates specialize in HIPAA security and compliance for Israeli medical device companies – and 2  questions always come up: “What is PHI?” and “What is electronically protected health information?” Of course, you will have already Googled this problem and come to one conclusion or another by surfing sites like Hipaa Compliance Made Easy or the Wikipedia entry on HIPAA. […]

  • Shock therapy for medical device malware

    Israel has over 700 medical device vendors.  Sometimes it seems like half of them are attaching to the cloud and the other are developing mobile apps for all kinds of crazy, innovative applications like Healthy.io ( Visual Input Turned Into Powerful Medical Insight – translation: an app that lets you do urine analysis using your smart phone). […]

  • Health Information Technology Patient Safety Action & Surveillance Plan

    This is a quick update on two new documents released by the HHS and the IMDRF:  Health Information Technology Patient Safety Action & Surveillance Plan The US Department of Health and Human Services published on July 2, 2013 the Health Information Technology Patient Safety Action & Surveillance Plan. The FDA belongs to the HHS. The plan defines several […]

  • Why security defenses are a mistake

    Security defenses don’t improve our understanding of the root causes of data breaches Why is this so? Because when you defend against a data breach – you do not necessarily understand the vulnerabilities that can be exploited. If do not understand the root causes of your vulnerabilities, how can you justify and measure the effectiveness of […]

  • 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 […]

  • Is cyber security and mobile device management important in the healthcare industry?

    Is cyber security and mobile device management important in the healthcare industry? Healthcare and technology go hand in glove more than almost any other sector in today’s business world. This statement is true today and will remain so into the future. Patient records form just one element of the vast mountain of data that is stored and […]

  • The facts of life for HIPAA business associates

    If you are a biomed vendor and you collect any  kind of PHI (protected health information) in your medical device or store information in the cloud (including public cloud services like Google Drive and Dropbox) you need to be aware of US healthcare information privacy regulation. As a medical device vendor selling to healthcare providers, hospitals, physicians and […]

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