Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Day Pitney LLP
Forced to respond to a stinging audit report recently released by the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) that found less than effective enforcement of the HIPAA privacy standards, HHS's Office for Civil Rights (OCR) will commence its long-awaited HIPAA audits in early 2016.
Dentons Worldwide
On October 1, 2015, the new versions of the following regulations will come into legal force and effect:
Day Pitney LLP
Forced to respond to a stinging audit report recently released by the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) that found less than effective enforcement...
Thompson Coburn LLP
In the first two articles in this series, Life Sciences Decoded explored the FDA's new Rule revamping the food Good Manufacturing Practices (cGMPs) and creating the new Hazard Analysis and Risk-Based Preventive Controls requirements.
Ostrow Reisin Berk & Abrams
While the trend is clearly toward physician employment by hospitals and health plans, many doctors would prefer to practice independently for as long as possible.
Ostrow Reisin Berk & Abrams
All physicians must have malpractice insurance. But all policies are not alike. It is critical that you choose one that fits your practice's needs.
Ostrow Reisin Berk & Abrams
Whether you are considering selling your medical practice or you have already made a firm decision to do so, three key preparation steps can help ensure a successful outcome.
Jones Day
In the September 8, 2015, Federal Register, USDA announced the development of an interagency assessment report titled "Climate Change, Global Food Security, and the U.S. Food System" to support the National Climate Assessment of the U.S. Global Change Research Program.
Jones Day
In the September 8, 2015, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") proposed under the Privacy Act of 1974, as amended, to establish a new system of records, titled "Consumer Complaint Monitoring System" ("CCMS") II.
Jones Day
In the September 21, 2015, Federal Register, FDA announced the availability of a draft Compliance Policy Guide ("CPG") titled "Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in Grains."
Day Pitney LLP
On September 29, the Committee on Ways and Means of the U.S. House of Representatives approved a reconciliation measure seeking to repeal several key provisions of the Affordable Care Act (ACA).
Seyfarth Shaw LLP
The acquisition of a property improved with a long-term care facility, in particular a skilled nursing facility ("SNF"), presents certain unique issues for a potential purchaser...
Duane Morris LLP
Ferrelli, hospitals, informed consent, James J. Ferrelli, Jarrell, Jarrell v. Kaul, Kaul, liability insurance, malpractice, malpractice insurance, medical malpractice, N.J.S.A.45:9-19.17, New Jersey, privileges, surgical centers, uninsured
Dykema Gossett
This is the third in a series of updates addressing the 340B Drug Pricing Program Omnibus Guidance published by the Health Resources and Services Administration (HRSA) on August 28, 2015 (Guidance).
Fox Rothschild LLP
The transition has been five years in the making due to a government delay in 2012.
McDermott Will & Emery
The U.S. Court of Appeals for the Fourth Circuit has agreed to hear an interlocutory appeal on the use of statistical sampling as a means of proving liability under the False Claims Act (FCA).
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
This series is devoted principally to the reporting requirements imposed by Internal Revenue Code §§ 6055 and 6056 as added by §§ 1502 and 1514 of the Affordable Care Act (ACA), respectively.
Reed Smith
On October 20, 2015, the HHS Office of the Assistant Secretary for Health, Office for Human Research Protections is hosting a public town hall meeting to respond to questions related to its September 8, 2015 proposed rule.
Jones Day
In the September 17, 2015, Federal Register, FDA announced the availability of two Risk Assessments ("RAs").
Jones Day
In the September 22, 2015, Federal Register, FDA proposed to amend certain regulations pertaining to registration and process filings related to acidified foods and thermally processed low-acid foods packaged in hermetically sealed containers (also known as "low-acid canned foods" or "LACF").
Latest Video
Most Popular Recent Articles
Stoll Keenon Ogden PLLC
If you think your business has a low risk of incurring fines for violating the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), think again.
Strasburger & Price, L.L.P.
In 2011, the US Supreme Court decided Sorrell v US, holding that "[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment."
Jones Day
The EMA issued a decision granting Novartis access to the requested reports on the basis that such documents did not contain "commercial confidential information."
Lane Powell PC
You should consult with legal counsel for assistance to determine whether, and how, HIPAA may impact your workplace and what other steps should be taken.
In the wake of Anthem's proposed acquisition of Cigna and Aetna's proposed acquisition of Humana, providers are lining up to be heard.
McGuireWoods LLP
The Centers for Medicare & Medicaid Services (CMS) recently proposed regulatory changes to the Stark Law that may ease certain compliance challenges.
While the new law codifies payment for chronic care management under the Medicare physician fee schedule, effective immediately, it leaves many of the details largely to CMS’s discretion.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The IRS recently issued final instructions for Forms 1094-B and 1095-B and Forms 1094-C and 1095-C.
Day Pitney LLP
In view of recent highly publicized cyber attacks and the resulting financial, regulatory and reputational risks, healthcare organizations should be highly focused on cyber security.
Patterson Belknap Webb & Tyler LLP
Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion).
Article Search Using Filters
Related Topics
Mondaq Advice Center (MACs)
Popular Authors
Popular Contributors
Font Size:
Mondaq on Twitter