Administrative Agency Health Privacy

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Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

Historic Moment: Husband Reports Wife’s HIPAA Violation Triggering Six Figure Penalty Against Employer

For the second time in history, the Office for Civil Rights (“OCR”) has imposed a civil monetary penalty (“CMP”) against a covered entity for violations of the Health Insurance and Portability Act (“HIPAA”). Lincare, Inc., a...more

New Ruling Challenges FTC Authority to Regulate Cybersecurity Based on “Possible Consumer Harm”

A Nov. 13, 2015 ruling supports the argument that various companies and lawyers have been making for years: the Federal Trade Commission is exceeding its authority in prosecuting cybersecurity breaches under Section 5 of the...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Company Prevails in Challenge to FTC Data Security Complaint

A recent decision by the Federal Trade Commission (FTC) Chief Administrative Law Judge (ALJ) dismissed the FTC’s complaint against LabMD, Inc. (LabMD) asserting the company’s alleged failure to protect consumer data in two...more

FTC Theory of Unrealized Consumer Injury Rejected in LabMD Data Security Case

In what could be a major setback for the Federal Trade Commission (FTC) in the data security arena, an Administrative Law Judge (ALJ) has ruled that an unfairness claim brought by the FTC under Section 5 of the FTC Act...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

Responding to Subpoenas and Other Requests for Personal Health Information: Take Them at Face Value

Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

Also In The News - Health Headlines - August 2015 #2

House Report Highlights Cybersecurity Concerns At The Department Of Health and Human Services – The U.S. House of Representatives Committee on Energy and Commerce released a report revealing that five operating divisions at...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

HIPAA Security Requirements Aren't Cloudy, Especially to Whistleblowers

Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) announced that it had entered into a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton,...more

Privacy and Security Guidance: Cloud Computing in the MUSH Sector

I. Purpose of this Guidance Document and How to Apply - This document is intended to be used by decision makers in the MUSH Sector when considering using cloud services....more

An Unforgiving NLRB Holds That Protecting Patient Data Under HIPAA Can Still Violate Section 7 Rights

It would make sense that the systems housing patient records at a physician’s office should be protected by a robust duty on the part of the physician’s employees to keep such records confidential. The purpose, of course, is...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

Comingling of employee and patient data compromises employer’s HIPAA defense to employee’s claim of discharge for union activity

An administrative law judge (ALJ) of the National Labor Relations Board has concluded that a health care employer’s use of its medical records software to store employee contact information allowed an employee to access that...more

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out...more

Healthcare Fraud Initiatives in 2015

In order to predict what 2015 will look like in the war against health care fraud, it is necessary to quickly review what happened in 2014. In 2014, the government’s health care fraud prevention and enforcement efforts...more

OCR Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more

ONC-HIT Releases Updated Guide for Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (ONC-HIT) released version 2.0 of its Guide to Privacy and Security of Electronic Health Information (the Guide). While the Guide clearly states that it...more

Spotlight on Responsibility and Accountability: OIG’s New Compliance Guidance for Health Care Governing Boards

On April 20, 2015, the Office of the Inspector General of the U.S. Department of Health and Human Resources (“OIG”), in collaboration with the American Health Lawyers Association, the Association of Healthcare Internal...more

HHS Settlement: Dumpster-Diving Leads to Settlement for Improper Disposal of Documents Containing Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (HHS) recently announced that it has reached an agreement with a small pharmacy to resolve potential HIPAA violations. The settlement arose from the...more

Pharmacy Pays $125,000 for Failure to Properly Dispose of Paper Records

Cornell Prescription Pharmacy (“CPP”), a Colorado single-location pharmacy, has agreed to pay $125,000 to the United States Department of Health and Human Services, Office for Civil Rights to settle alleged violations of the...more

Amidst Increasing Security Concerns, Medicare to Drop Social Security Numbers from Cards

In an effort to combat growing concerns of identity left, President Obama signed into law last week a bill that will require the removal of Social Security Numbers (SSNs) from all Medicare beneficiary cards. The change, which...more

HIPAA Enforcement Action, Breaches and Pilot Audits

During the HCCA Compliance on Monday, April 20, 2015, Iliana Peters, Senior Advisor for HIPAA Compliance and Enforcement, HHS Office of Civil Rights, presented “Lessons Learned from Recent HIPAA Enforcement Action, Breaches...more

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