Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to...more
On August 12, 2021, the Georgia Department of Community Health unanimously approved revisions to the rules for Personal Care Homes (PCHs) and Assisted Living Communities (ALCs). These revisions modify the Regulations for...more
On June 2, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced the 19th Resolution Agreement in the Health Insurance Portability and Accountability Act (HIPAA) Right of...more
On June 10, 2021, the Georgia Department of Community Health provided public notice of its intent to revise the regulations for Personal Care Homes and Assisted Living Communities. The revised regulations are intended to...more
On May 17, 2021, the Georgia Department of Public Health (DPH) issued an updated Administrative Order regarding reopening guidance for long-term care facilities. Commissioner Toomey previously issued an Order of reopening...more
On April 7, 2021, Commissioner Toomey of the Georgia Department of Public Health (DPH) issued an Administrative Order that provides new reopening guidance for long-term care facilities, which includes intermediate care...more
Effective July 1, 2021, Administrators of Assisted Living Communities and Administrators of Personal Care Homes with twenty-five (25) beds or more must hold licenses issued by the Georgia State Board of Long-Term Care...more
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently settled two additional enforcement actions as part of its HIPAA Right of Access Initiative, which is a program implemented by...more
New standards for assisted living facilities and personal care homes were among the changes included in Georgia House Bill 987, the “Disabled Adults and Elder Persons Protection Act,” which Governor Kemp signed into law on...more
With 2021 underway, covered entities should be mindful of the annual Health Insurance Portability and Accountability Act (HIPAA) small breach reporting deadline. HIPAA requires covered entities to report breaches of unsecured...more