Administrative Agency Health Privacy

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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

FDA Issues Guidance on Mobile Medical Devices

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

NIST Internet Of Things Framework Taking Shape

The National Institute of Standards and Technology (“NIST”) recently posted a preliminary discussion draft of its forthcoming Framework for Cyber-Physical Systems (a term used interchangeably with the Internet of Things, or...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

Today the Food and Drug Administration (FDA) published a notice announcing the availability of a draft guidance document entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The...more

UK Information Commissioner’s Office (ICO) Receives Power to Audit National Health Service

The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

Survey Says Sharing Information is Crucial in a Volatile Data Security Environment

Information sharing allows for better insight into existing threats and vulnerabilities and alerts organizations to the existence of important data that can help prevent cyberattacks and mitigate the effects of ongoing...more

Obama Administration the Target of Hackers; Former Administration Official Recipient of Subpoena Related to Cybersecurity

The Obama Administration's handling of cyber and data security was recently brought into question due to two distinct security incidents. On the same day that a former Administration official received a subpoena related to...more

Blog: FDA Cybersecurity Workshop for Healthcare

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for...more

FDA Flunks Data Security Exam

Last week, the HHS Office of Inspector General released a damning report on FDA’s data security: “The objective of this review was to determine whether the FDA’s network and external Web applications were vulnerable to...more

FDA Issues Cybersecurity Guidelines - Manufacturers of Medical Devices Encouraged to Develop Cybersecurity Controls

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the design of medical devices capable of connecting to the Internet, a network, or...more

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