Communications & Media Science, Computers & Technology Health

Read need-to-know updates, commentary, and analysis on Communications & Media issues written by leading professionals.
News & Analysis as of

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Mass Appeal of Off Label Use

Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a...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

Congress acts on opioid drug epidemic as judge unseals OxyContin files

Here are some developments worth watching in the nation’s battle against the epidemic of opioid drug misuse that killed 28,000 Americans in 2014 alone...more

Joint Commission lifts ban on physicians texting patient orders

The Joint Commission, which is the national accrediting organization for health care organizations, has long banned physicians using text messages to place orders for patient care due to data security concerns. In 2011, the...more

Health Alert (Australia) - May 9, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: JUDGMENTS Commonwealth. Federal Court 29 April 2016 - Australian Competition and Consumer Commission v Reckitt...more

Telemedicine nursing licensure compact legislation enacted in 6 states and 7 more right behind

In another case of technology out pacing the law, telemedicine has continued to push the limits of state medical professional licensure laws. Generally, physicians and nurses must be licensed in the state in which they...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

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

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

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

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

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

313 Results
|
View per page
Page: of 13

Follow Communications & Media Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×