Topic: health

JD Supra Corporate Brief: Stopping 23andMe Sales, Buying Privacy Liabilities, Changing Proxy Policies, Approving REIT Conversions

On November 27, 1924, the very first Macy’s Thanksgiving Day parade was held. As it should be… Happy Holidays! The FDA is routinely criticized in cases where regulation is perceived to stymy innovation. Shutting down 23andMe isn’t one of them… (Andrew Ittleman and Kelly Lightfoot, JD Supra Perspectives) Every mobile app that glitters is not… Read more »

New York City Employers Must Pay Sick Leave

“…the Act gives employees the right to carry over sick time from year to year or have it paid out at the end of the year, creates new notice and recordkeeping requirements for employers, and protects employees against retaliation for using sick time.” (Julie Levinson Werner, Lowenstein Sandler LLP) Companies that employ more than 15… Read more »

HIPAA Q&A: What’s the New Word on Data Breaches?

“The definition of a data ‘breach’ was changed. The Omnibus Rules replaced the more subjective ‘harm standard’ with a more objective test that requires the covered entity to determine (based on a four-factor risk assessment) whether protected health information has been ‘compromised.’” (Snell & Wilmer) One of the key components of the new HIPAA /… Read more »

Summary of Final Omnibus HIPAA/HITECH Rules

No time read all 563 pages of the US Department of Health and Human Services Office for Civil Rights’ HIPAA/HITECH Omnibus Rule? Here’s a summary of key points: Effective Date: “The Enforcement Rule changes are effective on March 26, 2013. The additional 180 days afforded for most of the provisions in the Final Rule apply… Read more »

New HIPAA Omnibus Rule Modifies Privacy and Breach Notification Requirements for Health Care Providers

“The Final Rule represents the most significant development in healthcare privacy law since the issuance of the final Privacy Rule and Security Rule a decade ago.” (Morgan Lewis) On January 17, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released its final omnibus rule, strengthening the… Read more »

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »

Biosimilars Benefit From Health Care Reform Decision

“With [the] Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern. Presumably it will be full speed ahead through the regulatory process, and we will see biosimilar applications for approval and attendant patent litigation before too… Read more »

Obama Health Care Reform: How Will The Supreme Court Rule? What Implications?

From Is that Legal?: Later this month, the US Supreme Court will hear oral arguments in U.S. Department of Health and Human Services v. Florida, the lawsuit chosen to give the Court an opportunity to rule on the constitutionality of the Patient Protection and Affordable Care Act. Here are three interesting… Read on: Obama Health… Read more »

HIPAA Compliance: 6 Audit Questions (and Answers) for Covered Entities

Late last year, members of the Senate Judiciary Committee challenged regulators to step up enforcement of the Health Insurance Portability and Accountability Act: “… the Subcommittee made clear that the [Office for Civil Rights’] efforts fell far short of its expectations, pointing out that, of tens of thousands of HIPAA complaints received by OCR since… Read more »

FDA Proposes Social Media Guidance on Off-Label Drug Use

It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while… Read more »

Mobile Medical App? There’s an FDA Draft Guidance For That.

We’re seeing interest in the Food and Drug Administration’s Draft Guidance, issued July 21, 2011, on the regulation of mobile medical applications which, according to the FDA, pose similar risks as other regulated medical devices.  We’ll continue to update this reading list as additional commentary and analysis comes in: Draft Guidance Clarifies How FDA Plans… Read more »