News & Analysis as of

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

Are Attorneys Entitled to “HIPAA Rate”?

Over the past year, numerous lawsuits and complaints to the HHS Office for Civil Rights (“OCR”) have been filed by plaintiffs’ attorneys over a seemingly obscure HIPAA issue – the rate that health care providers and their...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...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

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

FCC Clarifies the Requirements for Sending Wireless Calls and Text Messages to Patients

The Federal Communications Commission ("FCC") recently clarified questions surrounding wireless patient calls and text messages, and the requirements of the Telephone Consumer Protection Act (“TCPA”). The TCPA protects...more

OCR Launches Platform for Developer HIPAA Questions

The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA...more

Meaningful Use Audits: Proactive Tips for Success

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. If the provider has met all core...more

HIPAA Fine Underscores OCR’s Focus on Physician Group Compliance

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced a $750,000 fine and resolution agreement, including a Corrective Action Plan (CAP), for Cancer Care Group, P.C. (CCG), a...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Blog: HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and...more

Highlights from the Tenth CEO/Innovators Roundtable: June 4 – 5, 2015

This past June, leaders from health systems, outpatient services companies, health insurers, IT and equipment suppliers, health retailers, home care providers, pharmaceutical companies, and investors gathered in Chicago for...more

FCC’s New Order Provides Some Guidance for Imaging Centers Placing Autodialed Calls to Patients

The Telephone Consumer Protection Act (“TCPA”) protects consumers from unwanted telephone calls and text messages by requiring a business to obtain prior express consent before placing autodialed or prerecorded voice calls to...more

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

Recent Enforcement Shows the Importance of Encrypting Mobile Devices Containing Protected Health Information

With headlines every day announcing another release of Protected Health Information (PHI), providers are asking themselves – is there a way to protect against these breaches? Beyond improving the security of large...more

OCR Enters into $750,000 Settlement with Physician Practice for HIPAA Violations

On September 2, the Department of Health and Human Services Office of Civil Rights (OCR) announced a settlement with Cancer Care Group, P.C., a thirteen-physician oncology practice in Indiana related to violations of the...more

Avoiding the Costly “Robo No-No”

The Telephone Consumer Protection Act (“TCPA”) was enacted to protect consumers from intrusive robocalls, but Congress probably did not foresee that it would result in a windfall for plaintiff’s lawyers. Virtually every...more

OCR settlement reiterates importance of proactive security rule compliance

On September 2, 2015, the U.S. Department of Health & Human Services (HHS) announced that Cancer Care Group, P.C. (CCG), a physician practice located in Indiana, agreed to pay $750,000 as part of a settlement to resolve...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

Stolen Laptop Bag Leads to $750,000 Fine for Oncology Group

On September 2, 2015, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced a substantial settlement with an Indiana-based oncology group, Cancer Care Group, P.C. (CCG). Under the terms of...more

Crafting a more realistic business associate agreement

According to a recent survey by KPMG, eighty percent (80%) of health care executives report that their information technology systems have been compromised by cyber attacks. Most healthcare institutions, the survey found,...more

Clinically Integrated Networks: Privacy and Security Concerns with Sharing Data

The Centers for Medicare & Medicaid Services (CMS) is changing reimbursement methodologies for healthcare providers from a fee-for-service model to a value-based model. Healthcare providers are responding to the changing...more

Blog: Cancer Care Group Reaches Agreement to Settle Alleged HIPAA Violations

Last week, Cancer Care Group, P.C. (CCG), an Indiana radiation oncology practice, agreed to settle alleged violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by paying $750,000 and adopting...more

FCC Clarifies TCPA Exemptions for Health Care Calls

In 1991, Congress passed the Telephone Consumer Protection Act (“TCPA”), which was enacted to protect the privacy interests of consumers by placing restrictions on unsolicited contacts from automated telephone calls,...more

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