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Labs Need to Update Notice of Privacy Practices

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

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

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On July 31, 2014, the FDA provided to congress the “anticipated details” of its draft Guidance describing its framework for Laboratory Developed Tests (LDTs) and Companion Diagnostics (CDx) guidance.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

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

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

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

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

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…

HHS grants patients direct access to laboratory reports

HHS grants patients direct access to laboratory reports

February 3, 2014
By Ken Stineman
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The Department of Health and Human Services (HHS) announced the final rule allowing laboratories to deliver laboratory test reports directly to patients and their “personal representatives.” The rule is scheduled to be published in the Federal Register on February 6th. Under HIPAA, according to the new rule, laboratories that are “Covered Entities” are now required to…

Tagged: CLIA, HHS, HIPAA

NSA appoints first Privacy Officer

NSA appoints first Privacy Officer

January 29, 2014
By Ken Stineman
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The National Security Agency (NSA) has announced that it has named IAPP member Rebecca Richards, CIPP/US, CIPP/G, its first-ever Civil Liberties and Privacy Officer. The NSA announced the appointment in a press release today: http://www.nsa.gov/public_info/press_room/2014/civil_liberties_privacy_officer.shtml Last summer, President Obama had announced several initiatives to regain the public’s trust in the NSA and to make information…

Tagged: Privacy

Personalized Medicine World Conference Recap

Personalized Medicine World Conference Recap

January 28, 2014
By Ken Stineman
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Double-Helix spent Monday and Tuesday at the Personalized Medicine multidisciplinary community at the Personalized Medicine World Conference (PMWC) held at the Computer History Museum in Mountain View, CA . Great group of more than 1000 attendees attended this year. Looks like they will need a larger venue for 2015! The PMWC honored the CEO of Illumina,…

Tagged: Personalized Medicine

Renew EU Safe Harbor annually or face FTC penalties

Renew EU Safe Harbor annually or face FTC penalties

January 23, 2014
By Ken Stineman
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Twelve companies agreed this week to settle Federal Trade Commission (FTC) charges that they falsely claimed they were abiding by the Safe Harbor privacy framework, but had allowed their annual self-certification to lapse. The FTC has made enforcement of the US-EU and US-Swiss Safe Harbor a priority following recent European Commission’s critisicm that enforcement was…

Tagged: FTC, HIPAA, Privacy, Safe Harbor

Dermatology practice settles HIPAA violations for $150k

Dermatology practice settles HIPAA violations for $150k

January 5, 2014
By Ken Stineman
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Health and Human Services (HHS) announced on December 27th that Adult & Pediatric Dermatology, P.C., of Concord, Mass., (APDerm) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules with the Department of Health and Human Services, with a $150,000 payment. http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/apderm-agreement.html What…

Tagged: Breach, HHS, HIPAA

Auto Scaling comes to the AWS Management Console

Auto Scaling comes to the AWS Management Console

December 18, 2013
By Ken Stineman
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On December 10th, Amazon announced that the Auto Scaling feature is now easily configurable in the AWS Management Console. Amazon AWS Auto Scaling enables you to automatically launch or terminate Amazon Elastic Compute Cloud (Amazon EC2) instances based on user-defined policies, health status checks, and schedules. You can now create Auto Scaling Groups through the…

Illumina working to expand BaseSpace application ecosystem

Illumina working to expand BaseSpace application ecosystem

December 9, 2013
By Ken Stineman
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Double-Helix spent the day in San Francisco at the Basespace Developers meeting learning about their new initiative for “Native” Basespace applications. http://storify.com/UYG13/basespace-developer-meeting-west-coast-edition BaseSpace is Illumina’s cloud environment for the storage and analysis of Next Generation Sequencing (NGS) data. BaseSpace is hosted in Amazon AWS and the system is used by hundreds MiSeq NGS hardware users. In…

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