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»  Posts By   October 2015 

HIPAA: Do I Need to Report?

Many physicians may not fully understand the breach reporting requirements mandated by the Health Insurance Portability and Accountability Act (HIPAA) and further enforced by the Health Information Technology for Economic and Clinical Health (HITECH) Act. A breach is considered any acquisition, access, use or disclosure of Protected Health Information (PHI) which compromises the security or privacy of the PHI. However, if the disclosed PHI has been rendered unusable, unreadable, or...

OIG Reports on HIPAA Oversight Could Signal Changes in HIPAA Enforcement

Recent OIG reports signal an upcoming increase in OCR activity and oversight of HIPAA covered entities, even in the absence of a breach. On September 29th, the Office of Inspector General (OIG) in the U.S. Department of Health and Human Services (HHS) released two reports which reviewed the successes and shortcoming in the Office for Civil Rights' (OCR) oversight of Health Insurance Portability and Accountability Act (HIPAA) compliance for covered...

HIPAA Requirements and the Benefits to Being Proactive

It is likely you have seen headlines and possibly read a few articles about the risks and liabilities that physicians are exposed to if they don't adequately comply with the myriad of requirements under the HIPAA Privacy and Security Rules: "Don't Neglect Business Associate Agreements” reads one headline, "Closing HIPAA Compliance Gaps: Getting your Policies in Order," or "The Top Ten HIPAA Violations and How to Prevent Them" read a...

FDA Offers Interim Guidance on Enforcement Against Compounding Pharmacies Under 503A

While the Drug Quality and Security Act (DQSA), which created significant implications for compounders by effectively reinstating Section 503A the Federal Food Drug and Cosmetic Act (FD&C Act), was signed in November 2013, its full effect has not been entirely felt by traditional compounding pharmacies since specific provisions of Section 503 still require rulemaking or other action by the FDA. Nearly two years later, the FDA's intentions with regards to...

FDA Issues Interim Policy on Compounding Using Bulk Drug Substances Under 503A and 503B

The FDA recently issued an Interim Policy on compounding using bulk drug substances under Section 503A and 503B of the Food Drug and Cosmetic Act (FD&C Act) offering important guidance for compounding pharmacies. 503A Section 503A sets forth the conditions that must be satisfied for drug products compounded by a traditional pharmacy in order to be exempt from certain requirements of the FD&C Act (i.e., new drug registration requirements, CGMPs,...