Page:United States Statutes at Large Volume 123.djvu/288

 123STA T . 2 68PUBLIC LA W 111 –5—FE B.1 7, 2 0 0 9(e)AC C ES S TOC E R T AINI N F OR M ATION IN EL ECTRONIC F ORMAT .— I nap p lyi n gs e ct i o n 164 . 52 4o f title 45 , Co d e of Fede r al R eg u lations, int h ecasethataco v ered entity uses or m aintains an electronic health record w ith respect to protected health information of an individual— (1) the individual shall have a right to o b tain from such covered entity a copy of such information in an electronic format and, if the individual chooses, to direct the covered entity to transmit such copy directly to an entity or person designated by the individual, provided that any such choice is clear, con - spicuous, and specific and (2) notwithstanding paragraph (c)(4) of such section, any fee that the covered entity may impose for providing such individual with a copy of such information (or a summary ore x planation of such information) if such copy (or summary or explanation) is in an electronic form shall not be greater than the entity ’ s labor costs in responding to the re q uest for the copy (or summary or explanation). SEC.13406 .C ONDIT IONS ON CE R T A IN CONTACTS AS P ART O FH EA L TH CARE OPERATIONS. (a) M AR K ETIN G .— (1) IN GENERAL.—A communication by a covered entity or business associate that is about a product or service and that encourages recipients of the communication to purchase or use the product or service shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations, unless the communication is made as described in subparagraph (i), (ii), or (iii) of para- graph (1) of the definition of mar k eting in section 164.5 0 1 of such title. (2) P A Y MENT FOR CERTAIN COMM U NICATIONS.—A commu- nication by a covered entity or business associate that is described in subparagraph (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of title 45, Code of Federal Regulations, shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations if the covered entity receives or has received direct or indirect payment in exchange for making such communication, except where— (A)(i) such communication describes only a drug or biologic that is currently being prescribed for the recipient of the communication; and (ii) any payment received by such covered entity in exchange for making a communication described in clause (i) is reasonable in amount; ( B ) each of the following conditions apply— (i) the communication is made by the covered entity; and (ii) the covered entity making such communication obtains from the recipient of the communication, in accordance with section 164.50 8 of title 45, Code of Federal Regulations, a valid authori z ation (as described in paragraph (b) of such section) with respect to such communication; or (C) each of the following conditions apply— 42USC17936.