Administrative Agency Health Privacy

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Alert: FTC Commissioners Find LabMD's Failure to Implement Data Security Practices "Unfair"

On July 29, 2016, the Federal Trade Commission (FTC or Commission) announced its long-awaited decision in its LabMD enforcement action. The Commissioners reversed the decision of an Administrative Law Judge (ALJ) and held...more

Federal Trade Commission Holds Medical Laboratory Liable for Allegedly Unfair Data Security Practices

On July 29, the Federal Trade Commission (“FTC” or “Commission”) issued a unanimous Opinion and Final Order reversing the FTC Administrative Law Judge (“ALJ”) Initial Opinion issued November 13, 2015, which had dismissed the...more

Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

LabMD Opinion Reverses ALJ Decision; Articulates Standard for “Substantial Injury” Under the Unfairness Prong of the FTC Act for...

In a widely anticipated move, the Federal Trade Commission (FTC) has overruled a decision by its own Administrative Law Judge (ALJ) that had dismissed a case against a medical testing laboratory accused of unreasonable data...more

Companies That Collect Sensitive Consumer Data Should Note the FTC’s LabMD Ruling

The FTC has been a leader in enforcing cybersecurity issues in recent years, and just last week it issued a highly-anticipated decision on its authority to regulate cybersecurity as a form of unfair consumer practice under...more

Breaking News: FTC Vacates ALJ’s Ruling and Finds LabMD Liable for Unfair Data Security Practices

In a ruling issued this morning, the Federal Trade Commission found that LabMD, the defunct Atlanta-based cancer detection lab, failed to protect patient information and is liable for unfair data security practices. The...more

Client Alert - The Government Makes a Business Associate Pay: What HIPAA Covered Entities and Business Associates Can Learn from...

The government has entered into its first settlement with a HIPAA business associate, including a $650,000.00 monetary penalty, ushering in a new period of enforcement for third parties who use Protected Health Information...more

FTC Delays Ruling in LabMD Appeal

The Federal Trade Commission has decided to put off until late July a decision about whether to overturn a ruling by the agency’s chief administrative law judge in the closely watched data security action against LabMD, the...more

FDA issues guidance on the use of EHRs in clinical investigations

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more

More Than a Family Affair: Six-Figure HIPAA Penalty Upheld for Unrepentant Home Care Agency due to PHI Access by Spurned Spouse of...

The Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 and the regulations promulgated thereunder (“HIPAA”) should be now well-known to health care providers and health plans. Under HIPAA’s...more

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

Until Death Do Us Part – Divorce and HIPAA Violations: A Lesson in Safeguarding Protected Health Information

The Office of Civil Rights (“OCR”), a division of the Department of Health and Human Services, recently took the rare step of imposing civil monetary penalties against a large home health provider for violating the Health...more

OCR for the Win: Lincare, Inc. HIPAA Enforcement Action

For the second time in history, on January 13, 2016, an Administrative Law Judge (ALJ) upheld the imposition of civil money penalties charged against a covered entity by the Office of Civil Rights in the Department of Health...more

Six-Figure January HIPAA Enforcement Activities Highlight Importance of Maintaining Privacy Protections

The U.S. Department of Health & Human Services’ (“HHS”) Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) were each involved in the resolution of high profile privacy matters in January 2016. The two...more

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...more

Second CMP Assessed for HIPAA Violations: Do You Know Where Your Data Is?

For only the second time in its history, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed a civil money penalty (CMP) on a covered entity for allegedly violating the HIPAA...more

Blog: ALJ Upholds OCR Enforcement Against Lincare, Inc. of $239,800

A U.S. Department of Health and Human Services (HHS) administrative law judge (ALJ) recently sustained an earlier HHS Office of Civil Rights (OCR) decision to impose a civil money penalty (CMP) of $239,800 against Lincare...more

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

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