HB4059ham002 93RD GENERAL ASSEMBLY

Health Care Availability and Access Committee

Adopted in House Comm. on Mar 03, 2004

09300HB4059ham002 LRB093 15454 DRJ 48452 a

AMENDMENT TO HOUSE BILL 4059

AMENDMENT NO. ______. Amend House Bill 4059, AS AMENDED, in Section 5, Sec. 367.4, by replacing all of subsections (b) through (f) with the following:

"Summary health information" means information that may be individually identifiable health information and (i) that summarizes the claims history, claims expenses, or type of claims experienced by individuals for whom a plan sponsor has provided health benefits under a group health plan and (ii) from which the information described in subdivision (d)(2)(i) has been deleted, except that the geographic information described in subdivision (d)(2)(i)(B) need only be aggregated to the level of a 5-digit zip code.

(b) Except as otherwise provided in this subsection, a group health plan, in order to disclose protected health information to the plan sponsor or to provide for or permit the disclosure of protected health information to the plan sponsor by a health insurance issuer or health maintenance organization with respect to the group health plan, must ensure that the plan documents restrict uses and disclosures of such information by the plan sponsor consistent with the requirements of this Section.

The group health plan, or a health insurance issuer or health maintenance organization with respect to the group health plan, shall disclose summary health information to the plan sponsor if the plan sponsor requests the summary health information for the purpose of (i) obtaining premium bids from health plans for providing health insurance coverage under the group health plan or (ii) modifying, amending, or terminating the group health plan.

The plan documents of the group health plan must be amended to incorporate provisions to do the following:

(1) Establish the permitted and required uses and disclosures of such information by the plan sponsor, provided that such permitted and required uses and disclosures may not be inconsistent with this Section.

(2) Provide that the group health plan will disclose protected health information to the plan sponsor only upon receipt of a certification by the plan sponsor that the plan documents have been amended to incorporate the following provisions and that the plan sponsor agrees to:

(A) Not use or further disclose the information other than as permitted or required by the plan documents or as required by law.

(B) Ensure that any agents, including a subcontractor, to whom it provides protected health information received from the group health plan agree to the same restrictions and conditions that apply to the plan sponsor with respect to such information.

(C) Not use or disclose the information for employment-related actions and decisions or in connection with any other benefit or employee benefit plan of the plan sponsor.

(D) Report to the group health plan any use or disclosure of the information that is inconsistent with the uses or disclosures provided for of which it becomes aware.

(E) Make available protected health information.

(F) Make available protected health information for amendment, and incorporate any amendments to protected health information.

(G) Make available the information required to provide an accounting of disclosures.

(H) Make its internal practices, books, and records relating to the use and disclosure of protected health information received from the group health plan available to the Director for purposes of determining compliance by the group health plan with this Section.

(I) If feasible, return or destroy all protected health information received from the group health plan that the sponsor still maintains in any form and retain no copies of such information when no longer needed for the purpose for which disclosure was made, except that, if such return or destruction is not feasible, limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible.

(J) Ensure that the adequate separation required in paragraph (3) is established.

(3) Provide for adequate separation between the group health plan and the plan sponsor. The plan documents must do the following:

(A) Describe those employees or classes of employees or other persons under the control of the plan sponsor to be given access to the protected health information to be disclosed, provided that any employee or person who receives protected health information relating to payment under, health care operations of, or other matters pertaining to the group health plan in the ordinary course of business must be included in such description.

(B) Restrict the access to and use by such employees and other persons described in subparagraph (A) of this paragraph (3) to the plan administration functions that the plan sponsor performs for the group health plan.

(C) Provide an effective mechanism for resolving any issues of noncompliance by persons described in subparagraph (A) of this paragraph (3) with the plan document provisions required by this subsection.

(c) Standard: de-identification of protected health information. Health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual is not individually identifiable health information.

(d) Implementation specifications: requirements for de- identification of protected health information. A covered entity may determine that health information is not individually identifiable health information only if:

(1) A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable:

(A) Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and

(B) Documents the methods and results of the analysis that justify such determination; or

(2)(i) The following identifiers of the individual or of relatives, employers, or household members of the individual, are removed:

(A) Names;

(B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial 3 digits of a zip code if, according to the current publicly available data from the Bureau of the Census:

(i) The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than 20,000 people; and

(ii) The initial 3 digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000;

(C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;

(D) Telephone numbers;

(E) Fax numbers;

(F) Electronic mail addresses;

(G) Social security numbers;

(H) Medical record numbers;

(I) Health plan beneficiary numbers;

(J) Account numbers;

(K) Certificate/license numbers;

(L) Vehicle identifiers and serial numbers, including license plate numbers;

(M) Device identifiers and serial numbers;

(N) Web Universal Resource Locators (URLs);

(O) Internet Protocol (IP) address numbers;

(P) Biometric identifiers, including finger and voice prints;

(Q) Full face photographic images and any comparable images; and

(R) Any other unique identifying number, characteristic, or code, except as permitted by subsection (i) of this Section; and

(ii) The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

(e) Implementation specifications: re-identification. A covered entity may assign a code or other means of record identification to allow information de-identified under this Section to be re-identified by the covered entity, provided that:

(1) Derivation. The code or other means of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; and

(2) Security. The covered entity does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification.

(f)(1) Standard: minimum necessary requirements. In order to comply with this Section, a covered entity must meet the requirements of subdivisions (f)(2) through (f)(5) of this Section with respect to a request for, or the use and disclosure of, protected health information.

(2) Implementation specifications: minimum necessary uses of protected health information.

(i) A covered entity must identify:

(A) Those persons or classes of persons, as appropriate, in its workforce who need access to protected health information to carry out their duties; and

(B) For each such person or class of persons, the category or categories of protected health information to which access is needed and any conditions appropriate to such access.

(ii) A covered entity must make reasonable efforts to limit the access of such persons or classes identified in subdivision (f)(2)(i)(A) of this Section to protected health information consistent with subdivision (f)(2)(i)(B) of this Section.

(3) Implementation specification: Minimum necessary disclosures of protected health information.

(i) For any type of disclosure that it makes on a routine and recurring basis, a covered entity must implement policies and procedures (which may be standard protocols) that limit the protected health information disclosed to the amount reasonably necessary to achieve the purpose of the disclosure.

(ii) For all other disclosures, a covered entity must:

(A) Develop criteria designed to limit the protected health information disclosed to the information reasonably necessary to accomplish the purpose for which disclosure is sought; and

(B) Review requests for disclosure on an individual basis in accordance with such criteria.

(iii) A covered entity may rely, if such reliance is reasonable under the circumstances, on a requested disclosure as the minimum necessary for the stated purpose when:

(A) Making disclosures to public officials, if the public official represents that the information requested is the minimum necessary for the stated purpose or purposes;

(B) The information is requested by another covered entity;

(C) The information is requested by a professional who is a member of its workforce or is a business associate of the covered entity for the purpose of providing professional services to the covered entity, if the professional represents that the information requested is the minimum necessary for the stated purpose or purposes; or

(D) Documentation or representations that comply with the applicable requirements have been provided by a person requesting the information for research purposes.

(4) Implementation specifications: Minimum necessary requests for protected health information.

(i) A covered entity must limit any request for protected health information to that which is reasonably necessary to accomplish the purpose for which the request is made, when requesting such information from other covered entities.

(ii) For a request that is made on a routine and recurring basis, a covered entity must implement policies and procedures (which may be standard protocols) that limit the protected health information requested to the amount reasonably necessary to accomplish the purpose for which the request is made.

(iii) For all other requests, a covered entity must:

(A) Develop criteria designed to limit the request for protected health information to the information reasonably necessary to accomplish the purpose for which the request is made; and

(B) Review requests for disclosure on an individual basis in accordance with such criteria.

(5) Implementation specification: Other content requirement. For all uses, disclosures, or requests to which the requirements in this subsection (f) apply, a covered entity may not use, disclose, or request an entire medical record, except when the entire medical record is specifically justified as the amount that is reasonably necessary to accomplish the purpose of the use, disclosure, or request.

(g)(1) Standard: Limited data set. A covered entity may use or disclose a limited data set that meets the requirements of subdivisions (g)(2) and (g)(3) of this Section if the covered entity enters into a data use agreement with the limited data set recipient in accordance with subdivision (g)(4) of this Section.

(2) Implementation specification: Limited data set. A limited data set is protected health information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual:

(i) Names;

(ii) Postal address information, other than town or city, State, and zip code;

(iii) Telephone numbers;

(iv) Fax numbers;

(v) Electronic mail addresses;

(vi) Social security numbers;

(vii) Medical record numbers;

(viii) Health plan beneficiary numbers;

(ix) Account numbers;

(x) Certificate/license numbers;

(xi) Vehicle identifiers and serial numbers, including license plate numbers;

(xii) Device identifiers and serial numbers;

(xiii) Web Universal Resource Locators (URLs);

(xiv) Internet Protocol (IP) address numbers;

(xv) Biometric identifiers, including finger and voice prints; and

(xvi) Full face photographic images and any comparable images.

(3) Implementation specification: Permitted purposes for uses and disclosures.

(i) A covered entity may use or disclose a limited data set under subdivision (g)(1) of this Section only for the purposes of research, public health, or health care operations.

(ii) A covered entity may use protected health information to create a limited data set that meets the requirements of subdivision (g)(2) of this Section, or disclose protected health information only to a business associate for such purpose, whether or not the limited data set is to be used by the covered entity.

(4) Implementation specifications: Data use agreement.

(i) Agreement required. A covered entity may use or disclose a limited data set under subdivision (g)(1) of this Section only if the covered entity obtains satisfactory assurance, in the form of a data use agreement that meets the requirements of this Section, that the limited data set recipient will only use or disclose the protected health information for limited purposes.

(ii) Contents. A data use agreement between the covered entity and the limited data set recipient must:

(A) Establish the permitted uses and disclosures of such information by the limited data set recipient, consistent with subdivision (g)(3) of this Section. The data use agreement may not authorize the limited data set recipient to use or further disclose the information in a manner that would violate the requirements of this subpart, if done by the covered entity;

(B) Establish who is permitted to use or receive the limited data set; and

(C) Provide that the limited data set recipient will:

(1) Not use or further disclose the information other than as permitted by the data use agreement or as otherwise required by law;

(2) Use appropriate safeguards to prevent use or disclosure of the information other than as provided for by the data use agreement;

(3) Report to the covered entity any use or disclosure of the information not provided for by its data use agreement of which it becomes aware;

(4) Ensure that any agents, including a subcontractor, to whom it provides the limited data set agrees to the same restrictions and conditions that apply to the limited data set recipient with respect to such information; and

(5) Not identify the information or contact the individuals.

(iii) Compliance.

(A) A covered entity is not in compliance with the standards in this subsection (g) if the covered entity knew of a pattern of activity or practice of the limited data set recipient that constituted a material breach or violation of the data use agreement, unless the covered entity took reasonable steps to cure the breach or end the violation, as applicable, and, if such steps were unsuccessful:

(1) Discontinued disclosure of protected health information to the recipient; and

(2) Reported the problem to the Secretary.

(B) A covered entity that is a limited data set recipient and violates a data use agreement will be in noncompliance with the standards, implementation specifications, and requirements of this subsection (g).

(h)(1) Standard: Uses and disclosures for fundraising. A covered entity may use, or disclose to a business associate or to an institutionally related foundation, the following protected health information for the purpose of raising funds for its own benefit, without an authorization meeting requirements adopted by the Department:

(i) Demographic information relating to an individual; and

(ii) Dates of health care provided to an individual.

(2) Implementation specifications: Fundraising requirements.

(i) The covered entity may not use or disclose protected health information for fundraising purposes as otherwise permitted by subdivision (h)(1) of this Section.

(ii) The covered entity must include in any fundraising materials it sends to an individual under this paragraph a description of how the individual may opt out of receiving any further fundraising communications.

(iii) The covered entity must make reasonable efforts to ensure that individuals who decide to opt out of receiving future fundraising communications are not sent such communications.

(i) Standard: Uses and disclosures for underwriting and related purposes. If a health plan receives protected heath information for the purpose of underwriting, premium rating, or other activities relating to the creation, renewal, or replacement of a contract of health insurance or health benefits, and if such health insurance or health benefits are not placed with the health plan, such health plan may not use or disclose such protected health information for any other purpose, except as may be required by law.

(j)(1) Standard: Verification requirements. Prior to any disclosure permitted by this Section, a covered entity must:

(i) Verify the identity of a person requesting protected health information and the authority of any such person to have access to protected health information under this Section, if the identity or any such authority of such person is not known to the covered entity; and

(ii) Obtain any documentation, statements, or representations, whether oral or written, from the person requesting the protected health information when such documentation, statement, or representation is a condition of the disclosure under this Section.

(2) Implementation specifications: Verification.

(i) Conditions on disclosures. If a disclosure is conditioned by this subpart on particular documentation, statements, or representations from the person requesting the protected health information, a covered entity may rely, if such reliance is reasonable under the circumstances, on documentation, statements, or representations that, on their face, meet the applicable requirements.

(ii) Identity of public officials. A covered entity may rely, if such reliance is reasonable under the circumstances, on any of the following to verify identity when the disclosure of protected health information is to a public official or a person acting on behalf of the public official:

(A) If the request is made in person, presentation of an agency identification badge, other official credentials, or other proof of government status;

(B) If the request is in writing, the request is on the appropriate government letterhead; or

(C) If the disclosure is to a person acting on behalf of a public official, a written statement on appropriate government letterhead that the person is acting under the government's authority or other evidence or documentation of agency, such as a contract for services, memorandum of understanding, or purchase order, that establishes that the person is acting on behalf of the public official.

(iii) Authority of public officials. A covered entity may rely, if such reliance is reasonable under the circumstances, on any of the following to verify authority when the disclosure of protected health information is to a public official or a person acting on behalf of the public official:

(A) A written statement of the legal authority under which the information is requested, or, if a written statement would be impracticable, an oral statement of such legal authority;

(B) If a request is made pursuant to legal process, warrant, subpoena, order, or other legal process issued by a grand jury or a judicial or administrative tribunal is presumed to constitute legal authority.

(iv) Exercise of professional judgment. The verification requirements of this subsection (n) are met if the covered entity relies on the exercise of professional judgment in making a use or disclosure or acts on a good faith belief in making a disclosure.".