Privacy Health

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OCR Announces Guidance on Individual's Right to Access Health Information Under HIPAA

On January 7, 2016, the Office of Civil Rights (OCR) of the Department of Health and Human Services released a fact sheet and the first of a series of Frequently Asked Questions (FAQs) to explain an individual’s rights under...more

HHS proposes updates to confidentiality of Part 2 substance abuse treatment records

On February 5, 2016, the Department of Health and Human Services (HHS) issued proposes changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, also known as “Part 2 records” which were published...more

Managing the Cybersecurity Risks of the Medical Internet of Things

The cybersecurity ramifications of the Internet of Things (IoT) are perhaps nowhere more crucial—potentially a matter of life and death, in fact—than in the realm of medical devices. Until recent times, a potential hack of...more

Lincare, Inc. ordered to pay civil monetary fines for HIPAA violations

In an unusual scenario, in fact, only the second time in history, the Office for Civil Rights (OCR) was successful before an Administrative Law Judge (ALJ) in obtaining an order for the payment of civil monetary fines as a...more

SAMHSA Proposes Major Changes to Federal Substance Abuse Privacy Rule

On February 9, 2016, almost thirty years after the last substantive change to the federal regulations governing the confidentiality of alcohol and drug abuse patient records, the Substance Abuse and Mental Health Services...more

HHS OCR Issues Rule Modifying HIPAA In Effort To Fight Gun Violence

On January 4, 2016, the Department of Health and Human Services Office for Civil Rights (“OCR”) issued a rule modifying the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule to expressly...more

20 Days Left to File Your Annual HIPAA Breach Report

Did your organization experience a HIPAA breach involving fewer than 500 individuals in 2015? If so, remember to submit your mandatory report to the Secretary of HHS no later than February 29, 2016, through the online breach...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: Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in...more

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

Blog: FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...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

Utah Proposal Legislation Would Allow Security Cameras within Assisted Living Rooms

On February 1, 2016, the Utah Legislature's House Health and Human Services Committee debated proposed legislation permitting an assisted living facility resident, or their representative, to install a video or audio...more

Employment Law This Week: Equal Pay Data, HIV-Positive Employees, DOL’s Fiduciary Rule, NJ Harassment Defense [Video]

We invite you to view Employment Law This Week - a weekly rundown of the latest news in the field, brought to you by Epstein Becker Green. We look at the latest trends, important court decisions, and new developments that...more

FTC’s Proposed Settlement with Dental Practice Software Provider Marks Latest Data Security Action Against a Product Supplier

On January 5, the Federal Trade Commission (“FTC”) reached an agreement with Henry Schein Practice Solutions, Inc. (“HSPS”) to settle allegations that HSPS misrepresented that its dental practice software provided...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

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance details...more

Deadline for Reporting “Small” 2015 HIPAA Breaches Approaching

For those covered entities who experienced one or more HIPAA breaches involving less than 500 individuals during the calendar year 2015, the deadline for reporting those breaches to the Secretary of the U.S. Department of...more

FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with...

Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more

FDA's Expanding Views on Cybersecurity and Medical Devices: Draft Guidance on Postmarket Management of Cybersecurity

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through commercialization. In response to concerns about increased cybersecurity...more

FDA Releases Draft Guidance for Medical Device Cybersecurity

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more

Washington Healthcare Update

This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more

FDA applies postmarketing requirements to evolving medical device cyber-risks – key messages to manufacturers

With incursions on cybersecurity occurring daily across a variety of platforms, cybersecurity risks are top of mind for FDA and for the device industry....more

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