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Congress requests feedback on FDA Laboratory Developed Test proposed rule

Congress requests feedback on FDA Laboratory Developed Test proposed rule

March 21, 2024
By Ken Stineman
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Congressional Hearing Announced Congress is seeking feedback on the FDA proposed regulation of laboratory-developed tests (LDTs). This week, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) announced a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” There…

Apple upgrades iMessage to defend against quantum computing

Apple upgrades iMessage to defend against quantum computing

March 1, 2024
By Ken Stineman
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Apple Security Engineering Announcement Apple announced this week in their blog that they have: “rebuilt the iMessage cryptographic protocol from the ground up to advance the state of the art in end-to-end encryption…” The next step in Privacy Protection Researchers have warned that breakthroughs in Quantum Computing could make current encryption methods obsolete and put…

Double-Helix | MISA Solutions Partnership

Double-Helix | MISA Solutions Partnership

May 17, 2023
By Ken Stineman
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The Double-Helix and MISA partnership brings together deep skills in digital transformation in life sciences and clinical laboratories.

HHS Cybersecurity Task Force Provides Free Resources to Address Healthcare Cyberattacks

HHS Cybersecurity Task Force Provides Free Resources to Address Healthcare Cyberattacks

May 10, 2023
By Ken Stineman
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On April 17, 2023, the U.S. Department of Health and Human Services (HHS) 405(d) Program announced the release of several resources to help the Healthcare and Public Health (HPH) sector address cybersecurity concerns. New Resources from HHS Read the Press Release The Growing Threat: Cyber Criminals Focusing on Healthcare Among the sectors most heavily targeted…

CPRA Qualifies for California November Ballot

CPRA Qualifies for California November Ballot

June 25, 2020
By Ken Stineman
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California’s Secretary of State Alex Padilla announced the California Privacy Rights Act qualified for the state’s November ballot. Californians for Consumer Privacy Founder Alastair Mactaggart filed the required 623,212 signatures with California counties. The California Privacy Rights Act is a ballot initiative, which, if adopted, would replace the California Consumer Privacy Act (CCPA), which entered into force…

Critical Cybersecurity Vulnerability in Medtronic Implantables

Critical Cybersecurity Vulnerability in Medtronic Implantables

March 22, 2019
By Ken Stineman
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On March 21, external security researchers disclosed potential cybersecurity vulnerabilities in some Medtronic implantable devices and related products. These cardio-defibrillators are implanted in a patient’s chest to deliver small electrical shocks to prevent irregular or fast heartbeats. More than 20 different Medtronic defibrillators models are affected, including the CareLink programmer used by health professionals and…

Tagged: Cybersecurity

AWS re:Invent 2018

AWS re:Invent 2018

December 17, 2018
By Ken Stineman
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The AWS re:Invent Conference There were a huge number of product launches announced by Amazon as this years 2018 re:Invent conference held on Nov 25 -Nov 30 2018 in Las Vegas, NV. Next year’s reinvent scheduled for Dec 02-06, 2019 Las Vegas Launches Here are detailed blog posts & whats new pages for the re:Invent…

DevSecOps Case Study

DevSecOps Case Study

March 10, 2018
By Ken Stineman
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Double-Helix works with multiple precision medicine, healthcare, and Software-as-a-Service (SaaS) providers who provide solutions to healthcare, pharmaceutical, and biopharma companies. For organizations that handle sensitive data, it’s critical to maintain the highest security standards. Using DevSecOps principles can help companies continuously improve the security posture of their software and incorporate Security-by-Design practices. The scientific research SaaS…

Meltdown and Spectre

Meltdown and Spectre

January 5, 2018
By Ken Stineman
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Meltdown and Spectre exploit critical vulnerabilities in modern processors. These hardware design vulnerabilties allow programs to potentially steal data which is currently being processed on the computer. While programs are typically not permitted to read data from other programs, a malicious program can exploit Meltdown and Spectre to get hold of secrets stored in the memory…

AWS Expands HIPAA Eligible Services and Removes Dedicated Instance Requirement

AWS Expands HIPAA Eligible Services and Removes Dedicated Instance Requirement

June 3, 2017
By Ken Stineman
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Amazon Web Services News – May 2017 HIPAA Eligible Services Expanded AWS has expanded its HIPAA Compliance Program to include Amazon CloudFront, Amazon S3 Transfer Acceleration, AWS WAF, and AWS Shield as HIPAA eligible Services. If you have an executed Business Associate Agreement (BAA) with AWS, you can now use Amazon CloudFront to accelerate the delivery…

AWS re:Invent 2016 Product Announcements

AWS re:Invent 2016 Product Announcements

December 9, 2016
By Ken Stineman
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AWS re:Invent 2016 Product Announcements Amazon’s annual re:Invent conference wrapped up this past week in Las Vegas. There were quite a few exciting announcements across Analytics, App Services, Compute, Containers, Database, App Streaming, Dev Tools, Internet of Things, Storage, Mobile, Management Tools, Content Delivery, and Security. Analytics Amazon Athena – New Service Amazon Athena is an…

OCR HIPAA Phase 2 Audit Protocol Released

OCR HIPAA Phase 2 Audit Protocol Released

April 8, 2016
By Ken Stineman
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OCR HIPAA Audit Protocol OCR has released the protocol updated for the HIPAA omnibus rule and the recently-launched Phase 2 HIPAA compliance audits. OCR HIPAA Audit Protocol The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. OCR established a comprehensive audit protocol that contains the…

FDA Draft Guidance for Cybersecurity in Medical Devices

FDA Draft Guidance for Cybersecurity in Medical Devices

January 24, 2016
By Ken Stineman
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Management of Cybersecurity in Medical Devices On January 15, 2016, the Food and Drug Administration (FDA) issued draft guidance, “Postmarket Management of Cybersecurity in Medical Devices,” addressing cybersecurity and risk management of vulnerabilities in medical devices. FDA Device Regulation Guidance FDA Cybersecurity Workshop The guidance was published just prior to the FDA Cybersecurity Workshop held on January 20-21,…

Tagged: Cybersecurity, FDA, Medical Devices

Preemptible and Spot Instances: Compute on the Cheap

Preemptible and Spot Instances: Compute on the Cheap

September 8, 2015
By Ken Stineman
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On-demand high performance compute (HPC) can help to solve problems ranging from medical imaging, genomics, visualization, and machine learning. By leveraging the “spare” cloud capacity of major cloud vendors, costs and time required to solve difficult problems can be significantly reduced. Google announced this week that preemptible virtual machines are now generally available: https://cloud.google.com/compute/docs/instances/preemptible. They first offered the…

New AWS Services and Features announced at SF AWS Summit 2015

New AWS Services and Features announced at SF AWS Summit 2015

April 12, 2015
By Ken Stineman
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Amazon recently held the AWS Summit in San Francisco at the Moscone Center on April 9, 2015. Several new exciting services and offerings that expand the AWS ecosystem were announced. Four significant service offerings available now or coming soon include: Elastic File System (EFS); Amazon Machine Learning; EC2 Container Service (ECS); and AWS Lambda. …

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