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23andMe Suspends Health Related Reporting

23andMe Suspends Health Related Reporting

December 7, 2013
By Ken Stineman
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As of this week, Mountain View based 23andMe will no longer offer health-related results and reporting from its genetic tests. FDA Warning Letter In response to the U.S. Food and Drug Administration’s warning letter, 23andme announced on Thursday, December 5th: “At this time, we have suspended our health-related genetic tests to comply with the U.S.…

Tagged: DTC, FDA, Genetic Testing, SNP

Cybersecurity Challenges for Medical Devices

Cybersecurity Challenges for Medical Devices

December 5, 2013
By Ken Stineman
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Regulatory Guidance The FDA recently published guidance recommending that device manufacturers develop security controls in the design of their products to limit malfunctions resulting from computer viruses and attacks, and maintain the confidentiality, integrity, and availability of the device information. At the same time, the latest HIPAA regulations also require risk assessments and the implementation…

Tagged: Cybersecurity, FDA

Missed Opportunities that can cost you that dream job

Missed Opportunities that can cost you that dream job

December 4, 2013
By Molly Ryan
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Digital content specialist Erin Palmer suggests 7 career search and interviewing tips for the job hunter. It’s critical for the job hunter to do research about themselves and their prospective employer before interviewing for that dream job. Erin suggests common missteps including not googling yourself, not doing enough research about the company, being late for…

InVitae defends right to provide BRCA genetic testing

InVitae defends right to provide BRCA genetic testing

November 26, 2013
By Ken Stineman
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InVitae Corporation announced on November 26th that it plans to defend its right to provide naturally occurring genetic diagnostic testing and services including BRCA. https://www.invitae.com/en/press/invitae-responds-myriad-genetics-lawsuit/ In a complaint filed in Utah federal court, Myriad claims that InVitae is infringing on 11 patents for products that assess a patient’s risk for breast and other cancers. University…

FDA Clears First NGS System for Clinical Use

FDA Clears First NGS System for Clinical Use

November 26, 2013
By Ken Stineman
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The FDA granted premarket clearance for the Illumina MiSeqDx high-throughput, next generation gene sequencing instrument. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm This is the first benchmark sequencer designed and validated for the clinical market. The instrument is also CE marked for use internationally. They were able to successfully “benchmark” the performance of the system against a publicly available quality scored…

FDA sends warning letter to 23andMe

FDA sends warning letter to 23andMe

November 26, 2013
By Ken Stineman
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On November 22, 2013 the FDA sent a warning letter to 23andMe: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm The FDA listed “particularly concerning” intended uses including the assessment of BRCA-related genetic risk and response to drugs such as warfarin. The FDA indicated that 23andMe submitted 510(k) applications in 2012 for several of these conditions but had since failed to address…

NIST Releases preliminary Cybersecurity Framework

NIST Releases preliminary Cybersecurity Framework

November 12, 2013
By Ken Stineman
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The National Institute for Standards and Technology released its preliminary cybersecurity framework to provide guidance to “critical infrastructure owners” Critical infrastructure includes those groups that maintain information relating to health and other areas. The framework describes five Framework Core Functions: Identify, Protect, Detect, Respond, and Recover It also categorizes maturity and adoption into four implementation…

Circulating fetal DNA Patent Invalidated

Circulating fetal DNA Patent Invalidated

November 11, 2013
By Ken Stineman
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The U.S. District Court for the Northern District of California sided with Ariosa and invalidated multiple claims in Sequenom’s patent for the detection of fetal cell-free (cffDNA) in the blood-stream of pregnant women. Ariosa Diagnostics had asked the court to declare that its Harmony(tm) non-invasive prenatal test was not infringing on patent no.

FDA reaffirms commitment to Personalized Medicine

FDA reaffirms commitment to Personalized Medicine

November 11, 2013
By Ken Stineman
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Paving the way for Personalized Medicine On October 31st 2013, FDA published a new report titled: Paving the Way for Personalized Medicine – FDA’s Role in a New Era of Medical Product Development http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf The FDA report describes their perspectives on Personalized Medicine, Pharmacogenomics, Personalized Medical Devices, Targeted Therapy, Companion Diagnostics, and Whole Genome Sequencing.…

FDA Issues Mobile Medical Application Final Guidance

FDA Issues Mobile Medical Application Final Guidance

September 24, 2013
By Ken Stineman
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FDA released a Final Guidance today on Mobile Medical Applications. Physicians and consumers are increasingly using mobile devices for healthcare purposes. The agency has indicated that it will have a tailored approach and “focus on the minority of apps that pose the higher risk to patients and and will exercise discretion for the majority that pose…

Copier Costs Health Plan $1,215,780

Copier Costs Health Plan $1,215,780

August 16, 2013
By Ken Stineman
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In April 2010, Affinity Health Plan filed a Breach Report with the HHS Office for Civil Rights (OCR) as required by the Health Information Technology for Economic and Clinical Health, HITECH Act. Affinity reported that a photocopier they had previously leased was purchased by the CBS Evening News as part of an investigatory report and…

Tagged: Breach, HIPAA

FDA Drafts Medical Device Security Guidance

FDA Drafts Medical Device Security Guidance

July 30, 2013
By Ken Stineman
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The FDA is now recommending that medical device manufacturers and health care facilities think about cybersecurity and put appropriate safeguards in place to reduce the risk of failure due to unauthorized access or cyber attack. The FDA has released the following communications: Safety communication and notice http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm356423.htm Draft Guidance on Content of Premarket Submissions for Management…

Tagged: Cybersecurity, FDA

HIPAA omnibus rule deadline for laboratories and business associates

HIPAA omnibus rule deadline for laboratories and business associates

June 20, 2013
By Ken Stineman
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On Jan. 17, 2013, the Department of Health and Human Services (“HHS”) released the Omnibus Final Rule (“Final Rule”) that affects several aspects of the Health Insurance Portability Act of 1996 (“HIPAA”). The new rule becomes effective March 26, 2013, and Covered Entities and Business Associates must comply by September 23, 2013. The Final Rule…

Tagged: HIPAA, HITECH

Managing Identity in the Cloud

Managing Identity in the Cloud

June 14, 2013
By Ken Stineman
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Many of our life-science clients are adopting a “cloud-first” strategy, biasing their software selection to cloud-based software-as-a-service (SaaS) applications. They are able to leverage cloud offerings including as NetSuite, Workday, Service-Now, Microsoft Office 365, Google Apps, Concur, and more. However, each of these applications typically requires a username and password. Cloud Identity Providers (IdP) and…

Tagged: Cloud, Identity

Improve your Linked-In Brand

June 14, 2013
By Molly Ryan
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Linked-In is a critical tool in today’s job search. Prospective employers and network contacts will review your linked-in profile before they talk with you. Each week, make a goal to reach out to 1-2 past colleagues and prior business contacts. Develop your network – you’ll may be surprised on who might be able to…

Tagged: Job Search

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