Category: Uncategorized

Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office.  While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates.  Moreover, proposals directed at addressing the […]

Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices.  From the letter, the rationale for selecting these companies is that together they “control more […]

ALJ Upholds OCR Enforcement Against Lincare, Inc. of $239,800

A U.S. Department of Health and Human Services (HHS) administrative law judge (ALJ) recently sustained an earlier HHS Office of Civil Rights (OCR)  decision to impose a civil money penalty (CMP) of $239,800 against Lincare Inc. (Lincare) in  connection with HIPAA violations discovered after a breach of patient records.  This is only the second time […]

FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks.  The Guidance is the latest manifestation of a federal agency weighing in on the continually […]

Senate opts for “Step by Step” approach for innovation legislation

Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced  that he will pursue a “step by step” approach to crafting major biomedical innovation legislation.  This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan.

White House Publishes Precision Medicine Initiative Privacy Guidelines

*This post is co-authored by Vince Sampson 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, technology, and policies to empower all parts of […]

States Strengthen Laws Addressing Health Information Handling and Breach Response

Connecticut and Oregon were recently added to the increasing list of states  adopting stricter laws addressing the handling of health information and penalties in connection with breaches of health information.  Both states amended their respective data security and breach notification laws and they will now levy stricter requirements on entities that store or […]

Updated Guide to Privacy and Security of Electronic Information Released by ONC and OCR

The Office of the National Coordinator for Health Information Technology (ONC) in collaboration with the Office for Civil Rights (OCR) recently released its new updated guidance for the privacy and security of electronic information.  The Guide to Privacy and Security of Electronic Health Information (the Guide), last published in 2011, is […]

Medical Device Tax Repeal Shows Signs of Life

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. Last week the Senate Finance Committee, Subcommittee on Health Care, held a hearing to take testimony on the tax’s negative […]

Class Action Following Health Information Data Breach

As we discussed in our previous post, Premera Blue Cross (Premera) recently revealed that it suffered a massive data breach potentially exposing the personal data of 11 million customers.  On Thursday Premera was hit with a proposed class action lawsuit in Washington federal court accusing it of negligence associated with the […]