Tag Archives: Health Information Technology

FDA Issues Draft Guidance for Connected Medical Devices

Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.  As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.  This draft guidance … Continue Reading

Top 10 for 2016 – Happy Data Privacy Day

In honor of Data Privacy Day, we provide the following “Top 10 for 2016.”  While the list is by no means exhaustive, it does provide some hot topics for organizations to consider in 2016. EU/U.S. Data Transfer (status of Safe Harbor).  On October 6, 2015, the Court of Justice of the European Union (CJEU) ruled … Continue Reading

Top 15 for 2015 – Happy National Data Privacy Day

In honor of National Data Privacy Day, we provide the following “Top 15 for 2015.”  While the list is by no means exhaustive, it does provide some hot topics for businesses to consider in 2015. Inside Threats for Healthcare Providers and Business Associates.  While news reports of security risks often focus on hackings and breaches … Continue Reading

Top 14 for 2014

In honor of National Data Privacy Day, we provide the following “Top 14 for 2014.”  While the list is by no means exhaustive, it does provide critical areas businesses will need to consider in 2014. Location Based Tracking.  As the utilization of GPS enable devices becomes more and more prevalent, employers are often faced with … Continue Reading

CMS Seeks Emergency Review and Approval of its One-Hour Breach Notification Rule for Exchanges

Today, the Centers for Medicare and Medicaid Services (CMS) requested an "emergency review" of its recently proposed rule that "[Federally-facilitated Exchanges or FFEs], non-Exchange entities associated with FFEs, and State Exchanges must report all privacy and security incidents and breaches to HHS within one hour of discovering the incident or breach."  We reported on the proposed … Continue Reading

Maryland Attorney General Gansler Forms Internet Privacy Unit

Linking his announcement to National Privacy Day, January 28, 2013, Maryland Attorney General Douglas F. Gansler informed the public that his office has formed an Internet Privacy Unit. (See similar step taken by Connecticut AG) The stated purpose of the Unit is to protect the privacy of online users. The Unit will be charged with "monitor[ing] … Continue Reading

A Summary of the Final HIPAA Rule

As we continue to examine the final HIPAA privacy and security regulations, as amended by the HITECH Act and the Genetic Information Nondiscrimination Act, we pulled together a summary of some of the key points. We fully expect additional sub-regulatory guidance to be provided by OCR, such as frequently asked questions and sample business associate agreement … Continue Reading

Final HIPAA Regulations: “Business Associates” Include Subcontractors, Data Storage Companies (Cloud Providers?)

Under the HITECH Act, business associates are subject to the HIPAA privacy and security rules (the "HIPAA Rules") virtually to the same extent as covered entities. In addition to implementing this change for business associates ("BAs"), and providing additional guidance concerning what entities are business associates, the final HIPAA regulations issued last week also treat certain subcontractors of BAs as BAs directly subject to the … Continue Reading

OCR Releases Guidance on “De-Identification” of PHI under HIPAA

On Monday, the Office for Civil Rights released guidance regarding methods for de-identification of protected health information (PHI) in accordance with the HIPAA Privacy Rule and as required by the American Recovery and Reinvestment Act of 2009. HIPAA covered entities and business associates recognize the increasing risks related to handling "protected health information." One way to reduce these risks … Continue Reading
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