Privacy Health Consumer Protection

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Hey Dentists: No Business Associate Agreement, No Problem

According to the U.S. Health and Human Services Office for Civil Rights (OCR), dental practices are not required to have a business associate agreement with their dental laboratory before sharing protected health...more

Advice to Healthcare Providers on Ransomware from the Head of the FBI

On Wednesday, March 8, James B. Comey, Director of the FBI, was at Boston College to deliver the keynote address for the inaugural Boston Conference on Cyber Security (BCCS 2017). Director Comey addressed various industry,...more

Privacy and Information Security a Top Priority in California under Xavier Becerra

Governor Jerry Brown’s selection of Congressman Xavier Becerra to succeed (now Senator) Kamala Harris as the new Attorney General of California was a surprising move that brings into power in California a seasoned advocate of...more

OCR Releases Guidance on Reporting and Monitoring Cyber Threats

Last week, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) released new guidance on reporting and monitoring cyber threats. The guidance urges covered entities and business associates to...more

Advertising Law - March 2017

FTC Fights Back in LabMD Suit - The Federal Trade Commission demonstrated its intention to fight for the power to regulate data security by filing a 111-page brief with the U.S. Court of Appeals for the Eleventh Circuit...more

Charging for Medical Records Can Cost You

Health care providers often are unaware of federal laws that regulate the process by which they charge patients for copies of medical records. Many providers incorrectly assume that only the law of the state in which the...more

CMS Recommendations Regarding Protection from Cybersecurity Risks

On January 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued Recommendations to Providers Regarding Cyber Security. In general, the Recommendations are intended to remind providers and suppliers to keep...more

SAMHSA Issues Final Rule Modernizing Confidentiality Requirements for Patients Receiving Substance Use Disorder Treatment

Last month, the U.S. Department of Health and Human Services (“HHS”) Substance Abuse and Mental Health Services Administration (“SAMHSA”) released a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient...more

$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143...more

Want to Know Why Memorial Healthcare Systems Is Paying HHS OCR $5.5 Million?

On February 16, 2017, HHS OCR announced that Memorial Healthcare Systems (MHS) had paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of HIPAA’s Privacy and Security Rules...more

Technical Noncompliance with HIPAA Can Lead to Big Penalties

As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance initiatives in recent months and is poised to continue its enforcement...more

TCPA Violations Claimed Against Rady Children’s Hospital in San Diego

Rady Children’s Hospital-San Diego (Rady) was hit with a proposed class action in California federal court this week for alleged violations of the Telephone Consumer Protection Act (TCPA) for autodialed debt-collection calls...more

Cybersecurity 2017: The Year in Preview

Introduction - Cybersecurity was a prominent factor in 2016 in all aspects of government, business and personal affairs. Russian and other foreign national hacking has the potential to spark a new form of cold...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices

Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical’s Merlin@home transmitter....more

Final Rule Modernizes Substance Use Disorder Patient Record Confidentiality Regulations

On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its long-awaited final rule amending the confidentiality regulations at 42 CFR Part 2 (Part 2) that apply to federally...more

Blue Shield Of California Avoids TCPA Class Action Over Pre-Recorded Call

On January 13, 2017, the United States District Court for the Central District of California granted Blue Shield of California’s motion for summary judgment in a case on whether the insurer violated the Telephone Consumer...more

Substance Abuse and Mental Health Services Administration (SAMHSA) Issues Confidentiality of Alcohol and Drug Abuse Patient...

On January 13, 2017, SAMHSA issued a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (42 C.F.R. Part 2). SAMHSA also issued a Supplemental Proposed Rule requesting comments on...more

HHS Reaches $2.2 Million Settlement With Life Insurance Company For Impermissible Disclosure Of ePHI

On January 18, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) announced that it had agreed to a $2.2 million settlement with MAPFRE Life Assurance Company of Puerto Rico (“MAPFRE Life”),...more

Litigation Alert: The Third Circuit Holds That Allegations That Personal Information Was Improperly Disclosed in Violation of the...

Last week, the Third Circuit held that allegations of the unauthorized disclosure of personal information in violation of the Fair Credit Reporting Act (FCRA) constituted a de facto injury sufficient to confer standing at the...more

Recent HIPAA Enforcement Actions

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more

Blue Shield Avoids TCPA-Related Liability

A federal court in California recently granted a summary judgment motion filed by Blue Shield of California (“Blue Shield”), allowing it to avoid liability for alleged violations of the Telephone Consumer Protection Act...more

Do Routine Calls by Health Plans to Patients and Health Plan Members Constitute “Telemarketing” Under the Telephone Consumer...

Covered entities have a long list of laws and regulations governing their conduct, including their communications with patients, customers, and members. Specifically, the Health Insurance Portability and Accountability Act...more

Enough is Enough: Court Dismisses TCPA Class Action Against A Health Plan That Placed Reminder Calls To Its Members That They...

Plaintiffs across the country have continued to file class actions against companies of all stripe for violation of the Telephone Consumer Protection Act (“TCPA”), often for communications far afield from the classic...more

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Cybersecurity

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