News & Analysis as of

Telehealth and Consumer Subscription Models

Telehealth opportunities continue to grow at an exponential rate, aligning with the concurrent growth of retail and consumer-focused medicine. Capturing the retail sentiment, companies are looking to offer subscription-based...more

Health Alert (Australia) - September 28, 2015

In This Issue: -Judgments; Legislation; and Reports In This Issue: -Judgments; Legislation; and Reports Australia Federal Court Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC...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

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business

An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical practice or as a separate and new venture. Providers have determined that many aspects of the service...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

New Value-Based Insurance Design Model for Medicare Advantage Plans Is the First of Multiple Medicare Plan Innovations Anticipated...

On September 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced[1] the opportunity for plan sponsors to test value-based insurance design (“VBID”) in the Medicare Advantage (“MA”) market. VBID refers to...more

Medicare Telehealth Services in Puerto Rico

As U.S. health care providers continue to use telehealth, telemedicine, and virtual care services to expand their services and geographic footprint overseas, they are beginning to ask whether or not Medicare will cover...more

The Telehealth Top 10 for 2015

Telehealth continues to be an innovative alternative to traditional brick-and-mortar medicine. The number of providers offering telehealth services is rapidly increasing and states are enacting laws requiring health plans to...more

HRSA Issues 340B Program Omnibus Guidance

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

[Webinar] Beam It Up Safely: Navigating Data Privacy and Security in Telemedicine's Uncharted Territory - Sept. 17, 12:00pm EDT

Science fiction programs once imagined a future where a doctor on a spaceship could treat a patient on a distant planet using groundbreaking technology. The health care industry may not yet have made this giant leap, but...more

Telemedicine or just a gadget for fitness addicts? Mobile Health Apps and the law

Mobile health (mHealth) apps are becoming more and more popular. Back in 2013, more than 97,000 health apps were already on the market. According to the European Commission (EC), this figure now amounts to around 100,000...more

Colorado Medical Board Adopts New Telehealth Policies

On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Will the TELE-MED Act of 2015 Really Change Licensure Rules?

Congress is reviewing legislation designed to permit telemedicine providers to treat Medicare patients across state lines without the need for separate state licensure. The Telemedicine for Medicare Act of 2015 (S. 1778 and...more

Mobile health apps: Are they a regulated medical device?

With the proliferation of smartphones, the market for mobile applications (apps) has developed very rapidly in recent years, becoming a key driver of mobile health (mHealth) deployment. App developers have created health apps...more

Telemedicine Prescribers Should Read This Case: U.S. vs. Zadeh

Health care providers who use telemedicine for remote prescribing of controlled substances should pay close attention to an important case currently pending at the Fifth Circuit Court of Appeals. The case will decide whether...more

Maine Welcomes Telemedicine with New Board Guidelines

The Maine Board of Licensure in Medicine enacted new guidelines governing the practice of telemedicine and the use of technology to deliver health care services. Effective June 2014, Maine’s guidelines expand upon prior Board...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Does Delaware’s New Telemedicine Law Foreshadow Broader Payment Parity?

Nationwide, states continue to enact laws requiring commercial health plans to cover medical services provided via telemedicine to the same extent they cover medical services provided in-person. These laws are intended to...more

Non-Stark Law Proposed Changes to Policies and Payments under the Physician Fee Schedule for CY 2016

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule (“PFS”) for calendar year 2016 (the “Proposed...more

Health Care Update - July 2015 #2

Congress Slowly Works on Budget Reconciliation; ACA Reform Proposals Still Up in the Air - The FY 2016 budget resolution, which was agreed to by Congress this past April, included broad reconciliation instructions...more

Colorado Proposes New Telehealth Rules

The Colorado Medical Board proposed updated draft guidelines for the delivery of healthcare services via telehealth, as well as remote prescribing for new patients. Recognizing that “using telehealth technologies in the...more

Is My Telehealth App Subject to HIPAA?

Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and...more

Congress Wows With Medicare Telehealth Parity Act of 2015, But Will It Succeed?

Rep. Mike Thompson (D-CA) and co-sponsors Rep. Gregg Harper (R-MS), Rep. Diane Black (R-TN), and Rep. Peter Welch (D-VT) announced, on July 7, 2015, the introduction of the Medicare Telehealth Parity Act of 2015,...more

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