The Omnibus appropriations bill entitled the Fiscal Year 2016 Consolidated Appropriations Act released late Tuesday, includes language from separate cybersecurity bills that had previously passed in both the House of...more
On Monday, the White House released its Privacy and Trust Principles (the “Principles”) for the Precision Medicine Initiative (“PMI”). PMI is a federal initiative announced in the 2015 State of the Union to support research,...more
On October 27, the Cybersecurity Information Sharing Act (CISA) finally passed the Senate by a hefty margin of 74–21 (read the text of the bill as passed). Despite an escalation of opposition and rhetoric over the past couple...more
On Tuesday the Senate passed the Cybersecurity Information Sharing Act (CISA). The House had passed a similar bill, the Protecting Cyber Networks Act, in April of this year. The Act comes in the wake of many large scale data...more
10/30/2015
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CHIME ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Information Sharing ,
Pending Legislation ,
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Privacy Laws
Institutions that are in the process of developing competency-based education ("CBE") programs now have a clearer window to the US Department of Education's perspective on how federal student financial aid rules can...more
While Congress continues to consider (but not act on) nationwide student data privacy initiatives, the states continued to lead the charge in 2015. Earlier this year, we reported that, in 2014, 36 states introduced 110...more
In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more
In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more
On July 10, 2015, the Federal Communications Commission (FCC or Commission) released an order that purports to respond to numerous different petitions asking the agency for clarification regarding the federal Telephone...more
7/19/2015
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FCC ,
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Reassigned Phone Numbers ,
Revocation ,
Smartphones ,
TCPA ,
Text Messages
United States lawmakers are facing increasing pressure from technology and life science industry leaders to adopt an "innovation box" regime to level the playing field with foreign counterparts and prevent significant US job...more
Earlier today H.R. 6, “21st Century Cures” passed the House of Representatives by an overwhelming vote of 344-77. Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent...more
Last week, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of...more
The chairman of the Federal Communications Commission ("FCC") yesterday announced that the agency will consider making revisions to the FCC's rules implementing the Telephone Consumer Protection Act ("TCPA") to "crack down on...more
Yesterday, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative. ...more
Despite making it a priority following the 2014 elections, Congress has not been able to move legislation repealing the medical device tax. However, recent developments show that Congress may finally be making progress....more
Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. ...more
Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more
On February 27, 2015, President Obama released a draft of a proposed Consumer Privacy Bill of Rights Act (Proposal). The Proposal aims to protect the privacy of individual consumers on the Internet by (a) establishing...more
The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more
Not wanting to be left out of the digital heath conversation, the Federal Trade Commission (FTC) has increased its level of activity. On January 27th, the FTC released its Internet of Things (IoT) report and last week the...more
2/6/2015
On January 27, 2015, the Federal Trade Commission (FTC) released a staff report titled Internet of Things—Privacy and Security in a Connected World. The report summarizes the topics discussed and input provided by...more
Over the past two weeks, President Obama has made clear that cybersecurity continues to be a concern, and he and the administration are increasing their focus on the issue. ...more
On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more
After years of pundits saying "oh, major cyber legislation will pass this year," it may finally be happening. Last week Congress hammered out details on four different cyber bills that are intended to help the country move...more
Put another way, while what goes on in the Nation’s Capital may seem distant and unrelated to building and sustaining a business, failing to closely observe, understand and, when necessary, interact with Washington can be...more
7/29/2014