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Medical Billing Provider and its Former CEO Settle FTC Charges That They Misled Consumers About Collection of Personal Health Data

In an age when many of us briskly scroll through website terms and conditions and check, “I agree” without thinking, how should businesses design their websites to obtain proper authorization to access users’ sensitive...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

Just in Time for the Holidays: Another HIPAA Settlement

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution Agreement and Corrective Action Plan (CAP) to settle alleged violations of the...more

Recent HHS Settlement Highlights Importance of Updating HIPAA Compliance Programs

On December 8, 2014, the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Anchorage Community Mental Health Services, Inc. (ACMHS). The agreement, which...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Connecticut Supreme Court Issues Decision That Could Expand State Law Liability in Data Breach Class Actions for Businesses...

Health care providers have not escaped the recent proliferation of data breach class actions, but plaintiffs generally have been unsuccessful in bringing claims based on the Health Insurance Portability and Accountability Act...more

Just In Time for the Holidays: More Security Requirements From NIST

National Institute of Standards and Technology (NIST) has published draft recommendations aimed at securing the confidentiality of sensitive federal information located within non-federal entities’ information technology...more

California Health Care Providers Successfully Ward Off Data Breach Lawsuits

In a pair of recent cases, two California health care providers successfully warded off lawsuits arising from unauthorized data breaches of patient files. These cases illustrate that improper disclosure of electronically...more

FTC Competition Priorities

FTC Commissioner Julie Brill discussed the agency’s competition and consumer protection priorities in her keynote address last Thursday at the ABA’s Antitrust Fall Forum at the National Press Club in Washington. Brill led off...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Realizing the Potential of Telemedicine in China, Part 2: Data Privacy and Security

The Chinese market presents a tremendous opportunity for U.S. hospitals and providers, as long as the intricacies of data privacy and security issues are thoroughly understood. This includes Chinese regulations regarding...more

California Attorney General Releases Data Breach Report with Recommendations for Retailers and the Health Care Sector

On October 28, 2014, the California Attorney General (“AG”) released its second annual report detailing the security breaches reported to the AG’s office in 2013, and provided recommendations to both the industry and...more

California Attorney General Releases 2014 Data Breach Report and Recommendations, Finding More of the Same.

On October 28, 2014, Attorney General Kamala Harris released the second annual California Data Breach Report. The report detailed the nature and scope of data breach notifications that her office received in 2013. Her office...more

Company Claims “HIPAA Has No Teeth”, Will Start Notifying Affected Individuals of Security Breaches and Vulnerabilities that Have...

A company named SLC Security, LLC (“SLC”), recently announced that it will begin notifying individuals if it believes it has identified a security breach or vulnerability of a company and it has not received a satisfactory...more

Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of...more

Good News: California Extends Its Medical Data Breach Notification Requirement From 5 to 15 Days

On Sept. 18, 2014, California’s governor approved Assembly Bill 1755, extending California’s stringent breach notification deadline for medical information breaches from five business days to 15 business days for clinics,...more

California Extends Deadline for Reporting Breaches to the CDPH from 5 to 15 Business Days

On September 18, 2014, California Governor, Jerry Brown, signed Assembly Bill 1755 (“AB1755”) into law, amending breach notification provisions in the California Health and Safety Code applicable to licensed clinics, health...more

Blog: FDA Issues Final Cybersecurity Guidance for Medical Devices

On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber...more

FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management

On October 2, 2014, the Food and Drug Administration (“FDA”) released the final version of a guidance document entitled, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” As discussed in a...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

“LoProCo”, 12,915 Complaints, and Other Lessons from OCR/NIST

12,915 complaints were reported in 2013 to the Department of Health and Human Services Office of Civil Rights (“OCR”) according to Illiana L. Peters, Senior Adviser for HIPAA Compliance and Enforcement. Cozen O’Connor...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

Healthcare Legal News: Volume 4, Number 3 - Special Issue: HIPAA Update

Recent Trends in HIPAA Liability - Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including...more

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