General Business Health Communications & Media

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Ten Things to Know About the CMS Long-Term Care Requirements Final Rule

Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more

Locky Ransomware Continues to Hit Health Care Entities

FireEye Labs has reported that the Locky ransomware continues to hit the health care industry hard, and has increased in the month of August. Although the telecommunications, manufacturing and aerospace/defense...more

OCR Announces First HIPAA Enforcement Action against a Business Associate

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced an agreement with Catholic Health Services of the Archdiocese of Philadelphia (CHCS), settling allegations that CHCS violated the Health...more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

News Flash: An Agreement Between Competitors to Limit Advertising/Marketing Violates the Antitrust Laws

For the second time in less than a year, the U.S. Department of Justice (DOJ) has filed an antitrust complaint against hospital systems that agreed to not advertise on billboards or in print in each other’s home county. Last...more

FCC Proposed Rule Will Change Business Data Services (Also Known as Special Access) Marketplace

Public and Private Agencies' Rates Could Be Impacted - The FCC is expected to issue a Further Notice of Proposed Rulemaking on April 28 that will rewrite the rules that protect local governments, public agencies and...more

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team

Equipment Supplier/Dealer Bill Moving in Commerce - A bill that would tip the scales in contract negotiations between farm and yard equipment suppliers and their local dealers has passed the Senate and is now pending...more

Cuba: The Risks and Rewards for U.S. Businesses

Background - Last week, the Obama Administration announced that the President intends to visit Cuba next month. He will find a political mixed bag of optimism and resignation. American businesses will find an equally...more

The Give and Take of the 2015 Library of Congress Sec. 1201 Copyright Exemptions

I used to love working on cars. As a teenager I had a 1972 Karmann Ghia, which I could repair, MacGyver-like, with rubber bands, tinfoil, and sticks of chewing gum. But as automotive technology advanced, the prospect of...more

U.S. to China Health Care Arrangements: New Rules for Medical Institution and Service Advertisements

As U.S. hospitals and health care providers continue to explore China’s market for international health care business opportunities, including telemedicine, they often consider providing services or products to consumers...more

FCC Releases Guidance on Autodialing and Pre-Recorded Voice Calls to Wireless Phone Numbers

This past July, the Federal Communications Commission (“FCC”) released a ruling (the “Ruling”) interpreting the Telephone Consumer Protection Act (“TPCA”) restrictions on certain communications to wireless telephone numbers....more

SEC Settles FCPA Charges Tied to Payments to Health Care Professionals

The SEC filed another settled action in which payments to health care professionals at state owned entities in China were alleged to be violations of the Foreign Corrupt Practices Act. Although the company furnished extensive...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Telemedicine in Texas: New requirements approved by Texas Medical Board

Compliance with telemedicine rules are tricky these days, as many individual state medical boards regulate the practice of telemedicine within state borders. It is important to keep track of the changing laws related to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

Physician Plaintiff Bound by Arbitration Clause in Nonparty’s Contract

Today’s riddle: A physician sues defendants for defamation. The defendants move to compel the arbitration clause of a contract the physician used to have with a nonparty. The defendants win the argument. What’s the...more

Top Five Resolutions for Covered Entities and Business Associates in 2015

The New Year is here. It is time to make those 2015 resolutions, and not just those for getting fit and healthy. Resolve now to improve your organization’s compliance with the Health Insurance Portability and Accountability...more

Final Menu Labeling Rules Released by FDA

The U.S. Food and Drug Administration (FDA) released two final rules for menu and vending machine labeling on November 25, 2014. The long-awaited rules stem from provisions in the Affordable Care Act (ACA), the comprehensive...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

FDA Issues Revised Draft Reprints Guidance

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

China Solicits Comments on Post-Market Study Guidelines

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

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