Demonstrating a continued focus on information security, the Food and Drug Administration (FDA) published draft guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. As the title indicates, the draft guidance focuses on issues manufacturers should address in the development and design of medical devices prior to sale to consumers.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
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
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
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
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 …
Click on the link in this post for high-level compliance roadmap concerning the Omnibus Privacy Rule under HIPAA and HITECH for covered plans, providers and business associates.
Continue Reading Check Out Our Webinar Addressing the HIPAA, HITECH Omnibus Regulations
Breach involving software upgrade to online application system leads to allegations of HIPAA privacy and security failures, and a $1.7 million settlement payment to HHS.
Continue Reading Wellpoint pays $1.7 Million to Settle Potential HIPAA Violations
Are you a “non-Exchange entity” with respect to the healthcare exchanges coming later this year? If so you may become subject to a one-hour breach notification mandate.
Continue Reading One Hour Breach Notification Mandate Proposed Regarding Obamacare Health Exchanges
Big Data’s impact on medical devices pushes FDA to propose draft guidelines for cybersecurity.
Continue Reading FDA Provides Data Security Guidance for Medical Device Manufacturers
University’s $400,000 payment to HHS to settle HIPAA compliance allegations highlights critical role of risk assessments, and need for security policies and procedures.
Continue Reading Idaho State University Investigated by HHS Following Report of Data Breach