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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

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

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FDA Draft Guidance for Cybersecurity in Medical Devices

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Management of Cybersecurity in Medical Devices On January 15, 2016, the Food and Drug Administration (FDA) issued draft guidance, “Postmarket Management of Cybersecurity in Medical Devices,” addressing cybersecurity and risk management of vulnerabilities in medical devices.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

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

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. …

President Unveils Precision Medicine Initiative

January 30, 2015
By Ken Stineman
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JANUARY 30, 2015 President Obama hosts a White House event today to unveil his new “Precision Medicine Initiative.” The event kicks off today at 11 AM Eastern, and will feature “patients, researchers, clinicians and leaders in government and industry to announce details of his new Precision Medicine Initiative,” according to White House spokesman Josh Earnest. The proceedings will…

Tagged: Personalized Medicine, Precision Medicine

Labs Need to Update Notice of Privacy Practices

November 22, 2014
By Ken Stineman
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HIPAA Compliance Reminder Laboratories must now comply with changes to the HIPAA Privacy Rule that enhance patient rights and provide patients direct access to laboratory test results. HHS had delayed its enforcement of the requirement that certain HIPAA covered laboratories revise their Notice of Privacy Practices (NPP), but as of October 6, 2014, all HIPAA covered laboratories…

Tagged: HIPAA, NPP

Internet of Things (IOT) and EU Data Protection

September 29, 2014
By Ken Stineman
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On September 16, 2014 a European advisory body on data protection and privacy gave their opinion regarding the privacy of “smart things” are being made available which monitor and communicate with our homes, cars, work environment and physical activities. Companies and organizations developing Internet of things (IoT) applications should go beyond current European Union compliance requirements to…

FDA Outlines Plans for LDT Regulation

July 31, 2014
By Ken Stineman
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On July 31, 2014, the FDA provided to congress the “anticipated details” of its draft Guidance describing its framework for Laboratory Developed Tests (LDTs) and Companion Diagnostics (CDx) guidance. In the FDA press release they indicated they were reinforcing their commitment to personalized medicine and taking “steps to help ensure the reliability of certain diagnostic tests.” As requested by Congress,…

Tagged: FDA, LDT, Personalized Medicine

Amazon adds EBS Encryption

June 11, 2014
By Ken Stineman
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On May 21st, Amazon Web Services (AWS) added encryption at rest for Elastic Block Store (EBS) data volumes and related snapshots. Users of AWS can now encrypt data stored on an EBS volume at rest by setting a single option. Blog Article: http://aws.amazon.com/blogs/aws/protect-your-data-with-new-ebs-encryption/ User Guide: http://docs.aws.amazon.com/AWSEC2/latest/UserGuide/EBSEncryption.html Some History of EBS Encryption Solutions Previously, to encrypt data-at-rest on EBS, companies…

Tagged: AWS, Cloud

California Online Privacy Policy Guidelines

May 21, 2014
By Ken Stineman
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On Wednesday, May 21st The California Attorney General published recommendations to support companies in their work to provide privacy policy statements that are meaningful to consumers. Guidance: Making your Privacy Practices Public: Recommendations on Developing a Meaningful Privacy Policy The California Online Privacy Protection Act of 2003 (CalOPPA) requires operators of commercial web sites and online services to conspicuously post…

Stolen Laptops lead to $$ HIPAA Settlements

April 22, 2014
By Ken Stineman
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Two entities have paid the U.S. Department of Health and Human Services Office for Civil Rights (OCR) $1,975,220 collectively to resolve potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. After receiving a breach report of a stolen laptop from Concentra Health Services, an OCR investigation determined that multiple…

Heartbleed OpenSSL Bug Threat

April 9, 2014
By Ken Stineman
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What is Heartbleed? Researchers discovered a vulnerability in OpenSSL, one of the most commonly used crytopgraphic protocols for protecting web traffic. The vulnerability is found in the ‘heartbeat’ extension of the Transport Layer Security (TLS) protocol that allows a session to be kept alive. CVE-2014-0160 – OpenSSL TLS ‘heartbeat’ Extension Information Disclosure Vulnerability VU#720951 – Open SSL heartbeat…

Credit Cards and HIPAA

February 13, 2014
By Ken Stineman
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A laboratory client asked us today — “Is Stripe HIPAA compliant?” Many laboratories accept payments for laboratory testing by credit card. Credit Cards may be used for up-front payments, paying a co-pay, or a patient paying the balance after insurance pays for a laboratory test. Payment Services There are several electronic providers that make credit…

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Double Helix LLC
Double Helix Solutions, LLC
1296 Mayette Ave
San Jose, CA 95125
408.390.6948

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