Health Consumer Protection

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Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Lab tech indicted for identity theft

A lab tech working at a Las Vegas pediatric cardiology practice has been indicted on one count of illegal use and disclosure of patient health information and one count of aggravated identity theft. The lab tech had...more

New HIPAA Audit Program Expected in 2016

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a report reviewing the HIPAA audit program that is administered by the Office of Civil Rights (OCR). The OCR is responsible...more

New Medicaid RCOs Raise Antitrust Issues for All Participating Health Care Providers

Physicians and other health care providers who were practicing in the 1990s were involved in numerous attempts to organize themselves in order to be able to participate in and even financially survive the onslaught of managed...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

New York State Health Care—DSRIP, PPSs, COPAs and Antitrust “Immunity”

New York has received permission to use over $8 billion in Medicare and Medicaid funds to revamp how healthcare is provided throughout the State. As part of this process, the New York State Department of Health (DOH) is...more

DOJ Antitrust Head Remains Focused on Health Care in Era of Consolidation

Speaking at an industry conference on November 13, U.S. Assistant Attorney General Bill Baer reiterated the government’s focus on competition concerns in the health care industry. According to Baer, head of the Department of...more

CT AG slams Hartford Hospital and EMC for loss of laptop

True to his word, the Connecticut AG has aggressively entered the data privacy and security enforcement arena with a $90,000 settlement with Hartford Hospital and EMC. The AG has agreed to a payment of $90,000 from...more

Privacy Tip #9: Destroying prescription information

Have you ever noticed how much of your personal information is included on a prescription bottle and its packaging? Take a look next time you pick up a prescription at the pharmacy. The outer packaging may include your name,...more

HHS Office of Inspector General Calls for Increased Oversight and Enforcement of HIPAA

On September 29, 2015, the U.S. Department of Health & Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections, released two studies calling on the HHS Office for Civil Rights (OCR) to...more

What is the TCPA and Why is it of Concern to Long Term Care Facilities?

The Telephone Consumer Protection Act (TCPA) was enacted in 1991 to protect consumers, especially cell phone consumers, from unwanted robocalls and texts. The Act applies to virtually any company that utilizes auto-dialing...more

OIG Emphasizes Proactive Enforcement of Privacy Rule and Monitoring of Repeat Offenders

The Office of Inspector General’s (OIG) recently released Privacy Standards report assessed the Office for Civil Rights’ (OCR) oversight of covered entities’ compliance with the Privacy Rule as well as the extent to which...more

FTC Comments Discourage Legislation Purporting to Grant Antitrust Immunity for Health Care Providers

In late September, the Federal Trade Commission (FTC) submitted comments to the Virginia and Tennessee Departments of Health regarding each state’s proposed rules concerning hospital cooperation agreements. These proposed...more

Words Hurt: FTC Challenges Proposed Hospital Merger Using Parties’ Own Statements

The Federal Trade Commission (FTC or Commission) authorized action on November 6 to block the proposed merger of two hospitals located in Huntington, West Virginia. The FTC issued an administrative complaint alleging that the...more

Health Care E-Note - October 2015

For health care professionals who began accepting Meaningful Use incentive money at the outset of availability under the Medicare option in 2011, the year 2015 is an important year. By starting early, eligible health care...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

HIPAA and Text Messaging

Text messaging is pervasive. Doctors and other health care providers, covered entities, and business associates currently use (and embrace) the technology. Texting is easy, fast and efficient. It doesn’t require a laptop...more

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying...more

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to...more

OIG Pushes OCR to Step Up HIPAA Enforcement

In two recent reports, each with a specific focus, the OIG strongly recommended that the Office for Civil Rights (OCR) step up its HIPAA oversight and enforcement activities. One report assessed the OCR’s oversight of covered...more

More Data Vulnerabilities, Cyber Breaches Detected in Healthcare Exchanges

Government audits continue to reveal that millions of people’s personally identifiable information is at risk. Continuous audit reports by the Office of the Inspector General (OIG) of The Department of Health and Human...more

Manatt Digital Media - October 2015

In this newsletter, we highlight some of the ways digital technologies are transforming healthcare and the opportunities and challenges they present to individuals and businesses. We also introduce you to our team at Manatt...more

Checklist for Avoiding Diagnostic Errors

The “say what?” study last month describing the disturbing frequency of errors in medical diagnoses has prompted much navel-gazing in many quarters. ...more

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