Employment Law Issues for Health Care Employers
What patients misunderstand about their right of informed consent
Chiropractic Stroke: Informed Consent
Polsinelli Podcasts - What's Happening in Healthcare Deals in 2014?
OFCCPs New Veteran/Disability Regulations Are Now in Effect. Are You Ready?
Polsinelli Podcast - Health Care Payment Changes: From Service to Value
Polsinelli Podcast - Going it Alone: Factors Independent Hospitals Should Consider Before Joining a Hospital System
Polsinelli Podcast - What's Next in Health Reform 2014
Health Care Antitrust & the Supreme Court – Interview with Bruce Sokler, Member, Mintz Levin
The Deal's 2nd half M&A scene: Interview with Spencer Klein, Morrison Foerster
The Affordable Care Act: The Structure of Health Plans – Interview with Alden Bianchi, Member, Mintz Levin
What Is Driving Stepped Up Government Health Care Enforcement? – Interview with Hope Foster, Member, Mintz Levin
Polsinelli Podcast - Hot Topics From the President of the American Health Lawyers Association
Bill on Bankruptcy: The Market's Unquenchable Thirst for Junk
Polsinelli Podcast - HIPAA Changes Overview
Ventas' Debra Cafaro on why the Health Care asset class is well positioned in today's economy
Digital Health: Revolutionizing Healthcare
Hot Companies in Digital Health
Medical Malpractice Litigation
Digital Health: Where is the Action for Entrepreneurs?
Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices -
The FDA’s decision to not require a number of mobile health devices to go through the...more
A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement.
Government contractors must agree that the products they sell to the U.S. government under...more
In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more
On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more
When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question....more
On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more
On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more
In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more
It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more
The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more
On June 20, 2014, the United States Food and Drug Administration (FDA) issued a draft guidance document announcing that the agency does not intend to enforce the general regulatory controls applicable to medical device data...more
On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more
During its Annual Meeting on June 11, 2014, the American Medical Association (AMA) voted to approve a list of guiding principles for coverage of and payment for telemedicine services, designed to “foster innovation in the use...more
On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more
The draft guidance also enables some health IT manufacturers to avoid the device tax.
The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more
When one big industry sues another we learn a lot about how business as usual is conducted.
In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more
In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image...more
A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the...more
On June 17, 2014, Southern California Public Radio affiliate KPCC broadcasted a report about physician-owned distributors of implantable medical devices (“PODs”) and the legal and ethical concerns that are raised when POD...more
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