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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

A New Sheriff in Town: Federal Trade Commission Enforcement of Medical Information Security

A recent court decision found that the Federal Trade Commission (FTC) has authority to enforce the requirements for security of Protected Health Information, or PHI, as defined under the Health Information Portability and...more

September 22, 2014: Quickly approaching deadline to amend business associate agreements

The HIPAA Omnibus Rule, enacted last year, made a number of changes to the HIPAA privacy, security and breach notification rules. Some of these changes affected business associate provisions of the HIPAA privacy and security...more

Face video scan can trigger data protection breach?

Data protection breaches of health related sensitive data might occur through a mere video scanning an individual’s face according to a recent research....more

FBI Warning to Health Care Sector Holds True

In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

Hospital Operator Reports 4.5 Million Patients’ Data Stolen in Cyberattack

The Tennessee-based acute-care hospital chain Community Health Systems, Inc. (CHS), reported on August 18 that information on approximately 4.5 million patients was stolen from the company. CHS is one of the largest hospital...more

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