Home
Services
Blog
Company
Contact

Posts Aside Archives | Page 4 of 4 | Double-Helix

Category Archive

Home Archive by category "Posts Aside"

FDA reaffirms commitment to Personalized Medicine

November 11, 2013
By Ken Stineman
One Comment
Blog, Posts Aside

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

September 24, 2013
By Ken Stineman
Leave a Reply
Blog, Posts Aside

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

August 16, 2013
By Ken Stineman
Leave a Reply
Blog, Posts Aside

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

July 30, 2013
By Ken Stineman
2 Comments
Blog, Posts Aside

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communications: Safety communication and notice http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm356423.htm Draft Guidance on Content of Premarket Submissions for Management…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

June 20, 2013
By Ken Stineman
Leave a Reply
Blog, Posts Aside

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

June 14, 2013
By Ken Stineman
Leave a Reply
Blog, Posts Aside

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
Leave a Reply
Blog, Posts Aside

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

1
2
3
4

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

Privacy
Terms of Use
Company Overview
Contact Us