Communications & Media Health

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Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

Top Takeaways from IAPP

The world of privacy grows every day as more data goes through the cloud. The new trends and weekly data breaches make conferences like the Global Privacy Summit all the more relevant. Earlier this month we went to...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

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....more

Sixth Circuit Court of Appeals Affirms "Prior Express Consent" in Health Care Collections Case

Baisden v. Credit Adjustments, Inc., No. 15-3411, 2016 WL 561735 (6th Cir. Feb. 12, 2016) - The U.S. Court of Appeals for the Sixth Circuit held that two hospital patients consented to a debt collection agency's...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

FCPA compliance and Ethics Report-Episode 249-Reflections on Cuba, with Adam Turteltaub [Video]

In this episode, I share some reflections and observations on Cuba with Adam Turteltaub who was coincidently on a tour in Cuba at the same time as myself. ...more

Abbott Laboratories Prevails in False Claims Act Case

On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...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

DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare...more

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

Have a Health App? Consider these FTC Best Practices

Recently, the Federal Trade Commission (FTC) partnered with HHS’ Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), along with the Food and Drug Administration...more

NTIA Rulemaking Seeks Comments on Government Role in IoT

The National Telecommunications and Information Administration (NTIA), part of the Department of Commerce, is seeking public comment on the benefits, challenges and potential roles for the government in fostering the...more

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more

FTC Releases Mobile Health Apps Interactive Tool

Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more

You Can Pay Now or You Will Pay Later: FDA Issues a Warning Letter to a Pharmaceutical Company for a Misleading Patient Co-Pay...

On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more

Think Before You App: FTC Releases Compliance Tools for Health App Developers

The Federal Trade Commission furthered its outreach to the mobile app developer community last week by issuing new guidance for integrating privacy and security into mobile health apps, as well as an interactive online tool...more

Feds identify security vulnerabilities in state healthcare exchange websites

A Government Accountability Office (GAO) examination of the state-run health insurance exchanges for California, Kentucky and Vermont identified inadequate security measures in place to protect consumers’ personal...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

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