Consumer Protection Science, Computers & Technology Health

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OCR to Focus More Investigative Resources on Smaller HIPAA Breaches with Less Than 500 Individuals Affected

The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more

Healthcare Records Held Hostage: When ransomware attacks

Imagine for a moment that your hospital or physician practice suddenly cannot access its electronic medical records. There hasn’t been a natural disaster. No, instead you are inexplicably staring at a computer screen from an...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

OCR to Increase Investigations of Smaller HIPAA Breaches

HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect...more

Lessons for Businesses from FTC’s Opinion on LabMD’s Data Security Practices

The Federal Trade Commission (FTC) has issued an Opinion and Final Order finding that the data security practices of LabMD, Inc. were unreasonable, and therefore constituted an unfair act or practice in violation of Section 5...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

Record-Breaking HIPAA Settlement Sends Strong Message to Covered Entities

This month marked the largest HIPAA settlement to-date for a single entity. Advocate Health Care Network (“Advocate”) agreed to pay $5.5 million and adopt a corrective action plan after an investigation by the Department of...more

Latest OCR HIPAA Settlement Provides Lessons for Covered Entities

Capping off a busy month of HIPAA settlements, on August 4, the Office for Civil Rights (“OCR”) announced a $5.55 million settlement with Advocate Health Care Network (“Advocate”), the largest fully-integrated healthcare...more

University of Mississippi to Pay $2.75 Million for Alleged HIPAA Violations

On July 21, 2016, the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) announced a settlement with the University of Mississippi Medical Center (UMMC), stemming from a 2013 breach of...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

FTC Holds That Disclosure of Sensitive Medical Information Due to Lax Security Violates the FTC Act

Last week, three commissioners from the Federal Trade Commission (FTC) held in In the Matter of LabMD, Inc. that a company’s failure to implement reasonable security measures to protect sensitive consumer information on its...more

AMA Adopts Ethical Guidelines for Telemedicine Providers

At its annual meeting on June 13, the American Medical Association (AMA) adopted ethical guidelines for the use of telemedicine, affirming the organization’s support of the use of telemedicine technologies within the confines...more

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

2.7 Million Dollar HIPAA Settlement

Last week, Oregon Health & Science University (“OHSU”) agreed to pay $2.7 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule, Privacy Rule, and...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

Boosts in Ransomware Attacks Spark Multiple Government Agency Responses

Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

Is encryption the key to your data security?

With the increased rate of data breaches targeting personal information, an increased public awareness of online privacy, and an increasingly demanding regulatory landscape, large and small businesses are looking to...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

Cybersecurity News & Notes – July 2016 #3

In Case You Missed It: Court certifies class in suit against Apple. On July 15, 2016, U.S. District Judge Jon S. Tigar certified a class of users of the mobile app Path, who allege that Apple facilitated the app’s access...more

Entity Fined $650,000 in First HIPAA Settlement with a Business Associate

The possibility of business associates potentially being audited, investigated, and ultimately fined is now a reality. On June 24, 2016, the United States Department of Health and Human Services’ Office of Civil Rights...more

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