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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Women’s Health Care Group Notifies 300,000 About Ransomware Attack

Women’s Health Care Group of Pennsylvania has notified approximately 300,000 patients that their protected health information has been compromised by a ransomware attack....more

Protecting Communications From PR Privilege Issues

by Pepper Hamilton LLP on

Two recent cases in state appellate court show the risks of sharing privileged communications with public relations consultants. But they also provide practical guidance on how to protect the confidentiality of...more

Cyber Threats Equal Serious Threats

by Burr & Forman on

Every where you look these days, there seems to be another report of a cyber attack--attacks which do not discriminate based on industry type, size of business, or impact. In other words, everyone is vulnerable. In fact, the...more

More Telemedicine Food for Thought: Exception Five to the Haight Act’s In-Person Examination Requirement

In our July 10, 2017 post regarding telemedicine prescribing, we wrote about the seven exceptions to the Haight Act’s requirement that a provider and patient have an-person visit before a prescriber/practitioner can prescribe...more

AGs Weave Themselves Into Patchwork of Digital-Health Regs

by Pepper Hamilton LLP on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more

Office of the National Coordinator Issues Guidance After NotPetya Attack

Following the most recent ransomware attack, known as NotPetya, (among other nicknames), many health care entities were victims of the ransomware, which prompted the Office of the National Coordinator (ONC) to issue guidance...more

When Health Data Goes Missing: Largest Reported Ransomware Attack

In the aftermath of two powerful global ransomware attacks, a Michigan-based medical equipment provider has disclosed that hackers “encrypted our data files” and accessed more than 500,000 patient records in what is believed...more

Health Care Data Breaches Cost $380 per Record

A new study issued by Ponemon Institute, sponsored by IBM, reveals that healthcare data breaches still cost more than in other sectors. The Ponemon Institute’s calculation is that the average healthcare data breach costs...more

OCR Issues Reminder on Security Incidents

Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware...more

HHS Releases Health Care Industry Cybersecurity Task Force Report

Last week, the Department of Health and Human Services (HHS) issued its “Report on Improving Cybersecurity in the Health Care Industry,” which is the culmination of a year-long effort on behalf of the Cybersecurity Task...more

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

by Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

Health Update - June 2017

HIPAA and Emerging Technologies - Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more

Indiana Reverses Course on Telemedicine Prescribing and Controlled Substances Laws

by Foley & Lardner LLP on

Indiana has taken another step towards expanding the meaningful use of telemedicine in connection with clinical services and prescribing. HB 1337, signed by Governor Eric Holcomb and effective July 1, 2017, will allow...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

New HHS Cybersecurity Preparedness Checklist

by Carlton Fields on

The Department of Health and Human Services’ Office of Civil Rights (OCR) recently published a checklist to guide HIPAA-covered entities and business associates through an appropriate response to a ransomware or cybersecurity...more

OCR Issues Checklist for Responding to Cyber-Attack

The Office for Civil Rights (OCR) recently released guidance entitled “My Entity Just Experienced a Cyber-attack! What Do We Do Now?” The Checklist is a practical tool for health care entities and outlines several steps to...more

HHS Releases Health Care Industry Cybersecurity Task Force Report

Last week, the Department of Health and Human Services (HHS) issued its “Report on Improving Cybersecurity in the Health Care Industry,” which is the culmination of a year-long effort on behalf of the Cybersecurity Task...more

“Fireball” Malware a Threat to Health Care Industry

A new report released by Check Point has security personnel working in the health care industry particularly concerned and they are warning their colleagues about the existence of “Fireball.”...more

OCR Issues Reminder on Security Incidents

Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware...more

Data Privacy + Cybersecurity Insider - June 2017

by Robinson & Cole LLP on

The American Institute of CPAs (AICPA), has released a risk management reporting framework intended to "establish a common, underlying language for Cybersecurity risk management reporting — almost akin to US GAAP or IFRS...more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

Health System Paid $2.4 Million Settlement After Identification in a Press Release of a Patient Who Was Engaged in Fraud

by Dickinson Wright on

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a $2,400,000 settlement with Memorial Hermann Health System (“MHHS”) to resolve an investigation of an unauthorized disclosure of...more

WannaCry Also Encrypted Hospital Medical Devices

The fall-out from WannaCry continues, particularly in the healthcare sector. There are new reports that WannaCry affected at least two hospital systems in the U.S. and encrypted medical devices (power injector systems)...more

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Cybersecurity

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