Health Science, Computers & Technology

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Charges for Medical Records: Are You Compliant with HIPAA?

Through a series of releases in the first half of 2016, HHS Office for Civil Rights (“OCR”) issued guidance on the individual right of access to protected health information (“PHI”) provided under HIPAA. One topic with...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

HIPAA Enforcement on the Rise

After a number of years of little HIPAA enforcement activity, the tides appear to be turning. From September 2015 through April 2016, HIPAA settlements have averaged more than one a month. The dollar amounts involved are...more

MedPAC Releases Report to Congress on Medicare and the Health Care Delivery System

In June, the Medicare Payment Advisory Commission (MedPAC) released their final annual report to Congress detailing recommendations on a variety of Medicare payment system issues....more

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

[Webinar] Cloud licensing and health care data: Know the risks, learn the solutions - July 13th, 12:00pm CT

As identity theft and malicious attacks against clinical providers increase, more and more health care data is stored in the digital cloud. The health care industry is required to take special precautions when licensing...more

Zimmer Biomet Buys LDR Holding for $1 Billion

Warsaw, Indiana-based Zimmer Biomet Holdings Inc. recently announced it will purchase LDR Holding Corp. for approximately $1.0 billion. PR Newswire notes that Zimmer Biomet will commence a tender offer to acquire all...more

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

CMS Overhauls Clinical Laboratory Fee Schedule with Long-anticipated Final Rule

On June 17, 2016, CMS released a long-anticipated final rule revising the Medicare payment system for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) (the Final Rule). In 2018,...more

Illinois data breach law amended and includes new twists

Governor Bruce Rauner signed several new provisions into law amending Illinois’ Personal Information Privacy Act, including health insurance and medical information into the definition of personal information that triggers...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

Significant Hospital Related Mid-Year Updated OIG Review Activities

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

NIOSH Explores Workplace Exposure to Multi-Walled Carbon Nanotubes

The May 2016 issue of NIOSH Research Rounds includes an item entitled “Research Explores Workplace Exposure to Carbon Nanotubes.” The National Institute for Occupational Safety and Health (NIOSH) summarizes the following two...more

FDA’s Expedited Access Program: A Year in Review

A new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by...more

The Rocky Road of Evaluation for Digital Health Tools

Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter. (Add this post to the noise!) While some may decry the comparison, there is a lot we can learn from that...more

Health Care IT Program Discusses Alternative Payment Model Opportunities

A distinguished panel of providers, consultants and IT firms convened on Tuesday, June 21st in New York at the Foley and Lardner LLP offices to share a discussion focused on the convergence of IT spend and new value based...more

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

MedPAC Issues Recommendations on Medicare Drug, Post-Acute Care, and Other Payment Policies

MedPAC has released its June 2016 Report to the Congress on Medicare and the Health Care Delivery System. The report includes recommendations for a number of Medicare policy reforms and analyses of various health care market...more

Federal Jury Acquits Former Warner Chilcott President

On June 17, 2016, a federal jury in the District of Massachusetts acquitted Carl Reichel, the former president of specialty pharmaceutical manufacturer Warner Chilcott, on a single count of conspiracy to violate the federal...more

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

OCR Warns of HIPAA Risks in Third-Party Apps

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently issued a warning regarding vulnerabilities in third-party applications used by entities covered by HIPAA. The OCR warning applies...more

Connecticut's New "Right to Try" Law Provides Hope for Patients and Providers, but FDA Remains in the Driver's Seat

Connecticut has recently joined the wave of states enacting a so-called “Right to Try” law, which ostensibly permits terminally ill patients access to investigational drugs (including biologics) and medical devices as a...more

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized medical device data from device manufacturers...more

AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents

New Ethical Guidelines - On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

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