Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

New Year, New Telehealth Opportunities

As we reflect upon how the health care industry has changed in 2015 and what we expect to see in 2016, there is one area that stands out as having great promise for continued growth—telehealth....more

What the Administration Actually Can Do on Drug Pricing

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have...more

HHS proposes updates to confidentiality of Part 2 substance abuse treatment records

On February 5, 2016, the Department of Health and Human Services (HHS) issued proposes changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, also known as “Part 2 records” which were published...more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

NIOSH Extends Comment Period on Draft CIB on Health Effects of Occupational Exposure to Silver Nanomaterials

On February 10, 2016, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice extending the comment period on the draft NIOSH Current Intelligence Bulletin: Health Effects of...more

Managing the Cybersecurity Risks of the Medical Internet of Things

The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of...more

Charity's Patient Assistance Program Passes OIG Muster in Advisory Opinion 15-17

On December 28, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued OIG Advisory Opinion 15-17, approving a charity’s proposal to unveil a new patient assistance program dedicated to...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

Lincare, Inc. ordered to pay civil monetary fines for HIPAA violations

In an unusual scenario, in fact, only the second time in history, the Office for Civil Rights (OCR) was successful before an Administrative Law Judge (ALJ) in obtaining an order for the payment of civil monetary fines as a...more

SAMHSA Proposes Major Changes to Federal Substance Abuse Privacy Rule

On February 9, 2016, almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services...more

20 Days Left to File Your Annual HIPAA Breach Report

Did your organization experience a HIPAA breach involving fewer than 500 individuals in 2015? If so, remember to submit your mandatory report to the Secretary of HHS no later than February 29, 2016, through the online breach...more

The US Biosimilars Pathway: Key Questions

In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more

Second CMP Assessed for HIPAA Violations: Do You Know Where Your Data Is?

For only the second time in its history, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed a civil money penalty (CMP) on a covered entity for allegedly violating the HIPAA...more

Blog: 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...more

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference...more

Health Alert (Australia) - February 1, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 22 January 2016 - JLSP and Innovation Australia [2016] AATA 23 This...more

Blog: 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...more

Metal-on-Metal Hip-Implant Case End With Significant Jury Award

If the bellwether trial of a plaintiff who suffered complications from a metal-on-metal hip implant is any indication of future verdicts, Wright Medical Technology should be worried. A jury awarded $11 million to a woman...more

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine...more

Obama Launches Cancer Moonshot Task Force – But Where’s The Patent Power?

On January 28, 2016, the White House issued a Memorandum establishing the Moonshot Task Force “to double the rate of progress in the fight against cancer – and put ourselves on a path to achieve in just 5 years research and...more

Wright Medical Technology Files Brief In Support Of Post-Trial Motions In Hip Implant Case

A couple of months ago, we reported on a $10 million punitive verdict in the first hip implant case to go to trial against Wright Medical Technology. Last week, Wright Medical filed its opening brief in support of its...more

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

CMS Posts Revised Application for Meaningful Use Hardship Exceptions

On January 22, CMS posted a revised application and instructions for a hardship exception from the Meaningful Use program penalties in 2015. Under the new, streamlined application process, which CMS says is a temporary...more

3,797 Results
|
View per page
Page: of 152

Follow Health Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×