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HIPAA Omnibus Rule: Deadline Approaching to Update Grandfathered Business Associate Agreements

Although the HIPAA Omnibus Rule (the “Rule”) went into effect nearly 18 months ago, the transition period for bringing business associate agreements into compliance with the Rule’s new requirements will end on September 23,...more

Mishandling Medical Records Turns Into an $800,000 HIPAA-Compliance Mistake

A non-profit healthcare company agreed to pay $800,000 as part of a settlement with the U.S. Department of Health and Human Services (HHS) for allegedly mishandling 71 boxes of medical records in violation of the privacy rule...more

WEBINAR: Breach, Enforcement and Beyond: HIPAA Breach Notification Analysis and OCR Enforcement Activities

The Office for Civil Rights of the US Department of Health and Human Services revised the breach notification regulations last year in order to make the analysis of whether a breach occurred more objective. In addition, OCR...more

NIST Vetting Guidance Valuable for Health Care Organizations Seeking to Use Third-Party Apps

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share...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

Big Data in Health Care

The use of big data is now widespread in the U.S. health care system. At major industry conferences and in leading publications, big data has become a watchword for clinical care providers, private insurers, pharmaceutical...more

Final Meaningful Use Rule: CMS Loosens its Grip

The Centers for Medicare & Medicaid Services (“CMS”) finalized a rule on August 29th which should give providers some breathing room in complying with meaningful use requirements for the Electronic Health Record (“EHR”)...more

China Issues New Telemedicine Opinions for China and Foreign-Based Providers

Telemedicine providers and vendors doing business in China, whether based in China, the United States, or elsewhere, received new guidance on the use of telemedicine in China....more

Health Care Reform Implementation Update September 2014

Congress is back in session, and work on a Continuing Resolution is underway. The Affordable Care Act (ACA) is back center stage with House Republicans attaching a medical device tax repeal provision to a jobs package set for...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Wrap-Up of Federal and State Chemical Regulatory Developments (September 2014)

Health Activists' Petition Seeks Sunset Of CBI Claims: On August 21, 2014, six environmental health organizations filed a petition under Section 21 of the Toxic Substances Control Act (TSCA). The petition urges the U.S....more

September 22, 2014 – HIPAA Compliance Deadline for Business Associate Agreements Is Just Around the Corner

All business associate agreements (“BAAs”) must be updated and compliant with current Health Insurance Accountability and Portability Act (“HIPAA”) regulations by September 22, 2014. Failure to meet this deadline could result...more

Deadline to Update Business Associate Agreements for HIPAA is Approaching

The deadline for updating your health plan’s existing business associate agreements is rapidly approaching. The final regulations issued on January 25, 2013 under the Health Insurance Portability and Accountability Act...more

China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services

In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were...more

Drug-Device Apple Cart Upset Again

On September 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act)....more

Health Care Update - September 2014 #2

In This Issue: - National Health IT Week Begins Today - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care...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

340B Federal Drug Pricing Program September Update: Self-Disclosures

As part of its ongoing series of monthly 340B Federal Drug Pricing Program (340B Program) integrity updates, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) released an update on...more

California Court Dismisses CMIA Claim Based on Possession of Stolen Medical Data

A health organization narrowly averted paying a potential $4 billion in damages under the California Confidentiality of Medical Information Act (CMIA) for losing the medical records of more than 4 million patients. Plaintiffs...more

NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

OCR Reveals Information about Upcoming HIPAA Audits

At the Healthcare Information and Management Systems Society (“HIMSS”) Privacy and Security Forum this week, health information privacy senior advisor for the Office for Civil Rights (“OCR”) Linda Sanches revealed certain...more

Data protection authority investigates eHealth and wellness/fitness apps

eHealth and fitness/wellness applications are being investigated and potentially sanctioned by the Italian data protection authority that found half of them not compliant with applicable privacy laws....more

The Trend of Stricter State Data Breach Laws Continues with Florida

Florida’s new Florida Information Protection Act, Fl. Stat. § 501.171, became effective July 1, 2014. The new law repeals and replaces Florida’s existing data breach notification requirements (Fl. Stat. § 817.5681) with more...more

DEA Authorizes Take-Back Programs for Pharmacies

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

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