Page:United States Statutes at Large Volume 123.djvu/287

 123STA T . 2 67PUBLIC LA W 111 –5—FE B. 17 , 2 0 0 9ofwhet he r the p rote c te d he al th in for m ation can b ef u rther e x chan g ed for remuneration b y the entity recei v ing protected health information of that individual .(2)EXCEPTIONS . —P aragraph ( 1 ) s hall not apply in the fol - lowing cases ( A ) T he purpose of the exchange is for public health activities (as described in section 1 64 . 5 12(b) of title 45 ,C ode of F ederal R egulations). ( B ) The purpose of the exchange is for research (as described in sections 164.5 0 1 and 164.512(i) of title 45, Code of Federal Regulations) and the price charged reflects the costs of preparation and transmittal of the data for such purpose. (C) The purpose of the exchange is for the treatment of the individual, sub j ect to any regulation that the S ec- retary may promulgate to prevent protected health information from inappropriate access, use, or disclosure. ( D ) The purpose of the exchange is the health care operation specifically described in subparagraph (iv) of paragraph (6) of the definition of healthcare operations in section 164.501 of title 45, Code of Federal Regulations. (E) The purpose of the exchange is for remuneration that is provided by a covered entity to a business associate for activities involving the exchange of protected health information that the business associate underta k es on behalf of and at the specific re q uest of the covered entity pursuant to a business associate agreement. (F) The purpose of the exchange is to provide an indi- vidual with a copy of the individual ’ s protected health information pursuant to section 164.524 of title 45, Code of Federal Regulations. ( G ) The purpose of the exchange is otherwise deter- mined by the Secretary in regulations to be similarly nec- essary and appropriate as the exceptions provided in sub- paragraphs (A) through (F). ( 3 )RE GULA TIONS.— N ot later than 1 8 months after the date of enactment of this title, the Secretary shall promulgate regulations to carry out this subsection. I n promulgating such regulations, the Secretary— (A) shall evaluate the impact of restricting the excep- tion described in paragraph (2)(A) to require that the price charged for the purposes described in such paragraph reflects the costs of the preparation and transmittal of the data for such purpose, on research or public health activities, including those conducted by or for the use of the Food and Drug Administration and (B) may further restrict the exception described in paragraph (2)(A) to require that the price charged for the purposes described in such paragraph reflects the costs of the preparation and transmittal of the data for such purpose, if the Secretary finds that such further restriction will not impede such research or public health activities. (4) E F FECTI V E D ATE.—Paragraph (1) shall apply to exchanges occurring on or after the date that is 6 months after the date of the promulgation of final regulations imple- menting this subsection. Deadlin e .