Allows clinical labs to provide biological data analysis services upon the request of the person on whom the service is to be performed for personal genomics or biological data collection.
STATE OF NEW YORK
________________________________________________________________________
714
2013-2014 Regular Sessions
IN ASSEMBLY(Prefiled)
January 9, 2013
___________
Introduced by M. of A. ROSENTHAL -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to clinical laborato-
ries and biological data analysis
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 576-b of the public health law, as added by chapter
2 572 of the laws of 2002, is amended to read as follows:
3 § 576-b. Performance of certain clinical laboratory services upon
4 request. 1. (a) A clinical laboratory may perform a clinical laboratory
5 service (including accepting a specimen or assignment for examination
6 and rendering a report), that it is otherwise allowed to perform, upon
7 the request of the person on whom the service is to be performed and
8 render a report directly to the person, where the service is for the
9 same purpose as a test or collection device that has been approved or
10 cleared by the Food and Drug Administration of the United States Depart-
11 ment of Health and Human Services for sale or distribution to the public
12 on a direct or over-the-counter basis without a prescription from a
13 qualified health care practitioner.
14 (b) In addition to any clinical laboratory service authorized under
15 paragraph (a) of this subdivision, a clinical laboratory may perform a
16 clinical laboratory service (including accepting a specimen or assign-
17 ment for examination and rendering a report), that it is otherwise
18 allowed to perform, upon the request of the person on whom the service
19 is to be performed for personal genomics or biological data collection.
20 2. All services conducted pursuant to this section shall comply with
21 the standards for testing established by the department and with any
22 other laws of this state, including requirements for confidentiality and
23 pre-test and post-test counseling.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02344-01-3
A. 714 2
1 3. [The] (a) Except as provided in paragraph (b) of this subdivision,
2 the results of any test conducted pursuant to this section shall be
3 provided only to the person who requested the test. Such results shall
4 be provided in a clear and concise manner that is understandable by lay
5 persons and that identifies results indicating the need for referral to
6 a physician or other qualified health care practitioner.
7 (b) Where a clinical laboratory performs a clinical laboratory service
8 as provided for in this section, and where such service is for personal
9 genomics or biological data collection, when directed by the person
10 requesting such service, a clinical laboratory may send the results of
11 the service to an entity for biological data analysis services. Such
12 biological data analysis services shall not be considered a clinical
13 laboratory service under this article. The results of any biological
14 data analysis services shall be provided in a clear and concise manner
15 that is understandable by lay persons, and shall be sent directly to the
16 person requesting such analysis.
17 4. Nothing in this section shall authorize a clinical laboratory, or
18 an entity providing biological data analysis services, to engage in the
19 practice of any health care profession under title eight of the educa-
20 tion law. The report issued to a person for a test conducted pursuant to
21 this section shall contain a clear statement, presented in a prominent
22 manner, to the effect that the report should not be viewed as medical
23 advice and is not meant to replace direct communication with a physician
24 or other health care practitioner.
25 § 2. This act shall take effect immediately.
