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Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

FDA Issues Final Guidance For Medical Device Exchange of Patient Information

The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more

FDA Recalls St. Jude Medical Pacemakers for Cybersecurity Patches

The Food and Drug Administration (FDA) has issued a recall of 465,000 St. Jude Medical pacemakers in order to push a mandatory firmware patch of vulnerabilities in six types of radio controlled cardiac pacemakers....more

Drones Delivering Medical Supplies in East Africa but not in U.S.

Residents in remote areas of Tanzania and Rwanda in East Africa are receiving medical supplies through the use of drones, far surpassing similar efforts in the U.S., according to Robert Graboyes, a senior research fellow at...more

NIST Releases Draft Guidance On Securing Wireless Infusion Pumps In The Healthcare Industry

by Dentons on

On May 8, 2017, the National Institute of Standards and Technology (NIST), through its National Cybersecurity Center of Excellence (NCCoE), released a new draft NIST Cybersecurity Practice Guide (SP 1800-8) entitled “Securing...more

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

SAMHSA Continues to Update Rules Related to Substance Abuse Records

by Baker Ober Health Law on

On January 13, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the Final Rule to revise 42 C.F.R. Part 2 (Part 2 Regulations) – the federal regulations that govern the confidentiality of...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

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

by Cooley LLP on

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

by Ropes & Gray LLP on

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

by Perkins Coie on

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...

by WilmerHale on

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

by Carlton Fields on

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

by BakerHostetler on

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

by Locke Lord LLP on

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

by King & Spalding on

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?

by Davis Wright Tremaine LLP on

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

by Cooley LLP on

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

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Cybersecurity

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