HR 2878 IH

To protect the privacy of health information in the age of genetic and other new technologies, and for other purposes.

September 15, 1999

Mr. MCDERMOTT (for himself, Mr. STARK, Mr. RUSH, Mr. ROMERO-BARCELO, Mrs. MINK of Hawaii, Mr. FROST, Mr. NADLER, Ms. SLAUGHTER, Mr. LEWIS of Georgia, Mr. FRANK of Massachusetts, Mr. HINCHEY, and Mr. WEINER) introduced the following bill; which was referred to the Committee on Commerce, and in addition to the Committee on Government Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

To protect the privacy of health information in the age of genetic and other new technologies, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE- This Act may be cited as the `Medical Privacy in the Age of New Technologies Act of 1999'.

(b) TABLE OF CONTENTS- The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings and purposes.

Sec. 3. Definitions.

TITLE I--INDIVIDUALS' RIGHTS

Subtitle A--Review of Protected Health Information by Subjects of the Information

Sec. 101. Inspection and copying of protected health information.

Sec. 102. Correction or amendment of protected health information.

Sec. 103. Notice of information practices.

Subtitle B--Establishment of Safeguards

Sec. 111. Establishment of safeguards.

Sec. 112. Accounting for disclosures.

Sec. 113. Prohibition against retaliation.

TITLE II--RESTRICTIONS ON USE AND DISCLOSURE

Sec. 201. General rules regarding use and disclosure.

Sec. 202. Authorizations for disclosure of protected health information for treatment or payment.

Sec. 203. Authorizations for disclosure of protected health information for purposes other than treatment or payment.

Sec. 204. Creation of nonidentifiable and coded information.

Sec. 205. Next of kin and directory information.

Sec. 206. Emergency circumstances.

Sec. 207. Oversight.

Sec. 208. Accreditation.

Sec. 209. Public health.

Sec. 210. Health research.

Sec. 211. Judicial and administrative purposes.

Sec. 212. General requirements governing subpoenas.

Sec. 213. Additional requirements for law enforcement access.

TITLE III--SANCTIONS

Subtitle A--Civil Sanctions

Sec. 301. Civil penalty.

Sec. 302. Civil action.

Subtitle B--Criminal Sanctions

Sec. 311. Wrongful disclosure of protected health information.

TITLE IV--MISCELLANEOUS

Sec. 401. Regulations.

Sec. 402. Relationship to other laws.

Sec. 403. Effective dates.

Sec. 404. Applicability.

SEC. 2. FINDINGS AND PURPOSES.

(a) FINDINGS- The Congress finds as follows:

(1) Health information plays a vital role in every aspect of an individual's life. It includes some of the most sensitive information available about an individual.

(2) An individual's health information is currently accessible to many people who do not need the information to provide health care to the individual, often without the individual's knowledge or consent.

(3) Individuals will be deterred from using the health care system unless they are assured that the confidentiality of their health information will be respected.

(4) There exists little Federal protection of the confidentiality of an individual's health information.

(5) While health information often is transferred across State lines, protection of the confidentiality of health information varies greatly from State to State, with little protection in some States.

(6) New technologies increase the importance of addressing new threats to the confidentiality of health information. For example, technologies that permit an individual's health information to be computerized increase the possibility of unauthorized electronic access to the information. Technologies that provide genetic information provide information not just about an individual's current health but also about the individual's potential future health and the health of the individual's relatives. This creates potential new uses and abuses of genetic health information that need to be addressed by legislation.

(7) The potential benefits from new genetic technologies will not be realized if individuals cannot trust that their health information is safe from unauthorized uses.

(b) PURPOSES- The purposes of this Act are as follows:

(1) To recognize that there is a right to privacy with respect to health information, including genetic information, and that this right must be protected accordingly.

(2) To ensure that an individual's interest in the privacy of their health information cannot be overridden without meaningful notice and informed consent, except in limited circumstances where there is a compelling public interest.

(3) To provide individuals--

(A) access to health information of which they are the subject; and

(B) the power to challenge the accuracy and completeness of, and amend or correct, records containing such information.

(4) To establish a minimum Federal standard for the protection of health information which will promote confidentiality while allowing efficient transfer of health information between States.

(5) To help ensure the confidentiality of computerized or electronically transferred health information.

(6) To restrict the gathering of aggregate health information for financial gain or other purposes without each subject's knowledge or consent.

(7) To establish strong and effective remedies for violations of this Act.

SEC. 3. DEFINITIONS.

As used in this Act:

(1) ACCREDITING BODY- The term `accrediting body' means a body, committee, organization, or institution that has been authorized by law, or is recognized by a health care regulating authority, with respect to accreditation, licensing, or credentialing of health care providers or health care facilities.

(2) CODED HEALTH INFORMATION- The term `coded health information' means any protected health information--

(A) in which all identifying information has been replaced by a unique identifier, and where neither the remaining information nor the unique identifier, on its face, identifies an individual;

(B) which cannot easily be used or manipulated in a manner that reveals the identity of an individual; and

(C) which can only be linked or matched to other information in a manner that reveals the identity of an individual by a person authorized to carry out such functions under section 204.

(3) DISCLOSE- The term `disclose' when used with respect to protected health information that is held by a health information trustee, means to release, transfer, provide access to, or otherwise divulge the information to any person other than an individual who is the subject of the information. Such term includes the placement of protected health information into a computerized data base, networked computer system, or any other electronic or magnetic data system, that more than one person may access by any means. Such term does not include oral communication between an individual who is the subject of protected health information and a health care provider delivering health care to such individual.

(4) ELECTRONIC- The term `electronic', when used with reference to information, means--

(A) in electronic or magnetic form;

(B) in an optical storage form;

(C) computer-based;

(D) computer-associated; or

(E) in some other form that--

(i) is appropriate for non-paper-based information processing or storage; and

(ii) exists on the date of the enactment of this Act or is developed subsequent to such date.

(5) HEALTH CARE- The term `health care' means--

(A) any sale or dispensing of a drug, device, equipment, or other item to an individual, or for the use of an individual, pursuant to a prescription; and

(B) any preventive, predictive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, counseling, service, or procedure--

(i) with respect to the physical or mental condition of an individual; or

(ii) affecting the structure or function of the human body or any part of the human body, including individual cells and their components.

(6) HEALTH CARE PROVIDER- The term `health care provider' means a person who, with respect to a specific item of protected health information, receives, creates, uses, maintains, or discloses the information while acting in whole or in part in the capacity of--

(A) a person who is licensed, certified, registered, or otherwise authorized by law to provide an item or service that constitutes health care, in the ordinary course of business or practice of a profession; or

(B) a Federal or State program that directly provides items or services that constitute health care to beneficiaries.

(7) HEALTH INFORMATION TRUSTEE- The term `health information trustee' means--

(A) a person who is a health care provider, health plan, health oversight agency, public health authority, health researcher, employer, insurer, school, institution of higher education, or insurance support organization, insofar as the person creates, receives, obtains, maintains, uses, or transmits protected health information; or

(B) any employee, agent, or contractor of a person described in subparagraph (A), insofar as the employee, agent, or contractor creates, receives, obtains, maintains, uses, or transmits protected health information.

(8) HEALTH OVERSIGHT AGENCY- The term `health oversight agency' means a person who--

(A) performs or oversees the performance of an assessment, investigation, or prosecution relating to--

(i) compliance with legal or fiscal standards pertinent to health care fraud, including fraudulent claims regarding health care, health services or equipment, or related activities and items; or

(ii) the protection of individuals from harm, abuse, neglect, or exploitation; and

(B) is a public agency, acting on behalf of a public agency, acting pursuant to a requirement of a public agency, or carrying out activities under a Federal or State law governing an assessment, investigation, or prosecution described in subparagraph (A).

(9) HEALTH PLAN- The term `health plan' means any health insurance plan, including any hospital or medical service plan, dental or other health service plan or health maintenance organization plan, or other program providing payment for health care, whether or not funded through the purchase of insurance.

(10) HEALTH RESEARCHER- The term `health researcher' means a person who conducts, using protected health information, a systematic investigation, or research development, testing, or evaluation, to develop or contribute to scientific or medical knowledge.

(11) INDIVIDUAL REPRESENTATIVE- The term `individual representative' means any individual legally empowered to make decisions concerning the provision of health care to an individual (where the individual lacks the legal capacity under State law to make such decisions) or the administrator or executor of the estate of a deceased individual.

(12) INSURANCE SUPPORT ORGANIZATION-

(A) IN GENERAL- Subject to subparagraph (B), the term `insurance support organization' means any person who regularly engages, in whole or in part, in the practice of assembling and providing information about individuals to an insurer or health plan for insurance transactions, including--

(i) the furnishing of consumer reports or investigative consumer reports to an insurer or health plan for use in connection with an insurance transaction; or

(ii) the collection of personal information from insurers, health plans, or other insurance support organizations for the purpose of detecting or preventing fraud or material misrepresentation in connection with insurance underwriting or insurance claim activity.

(B) PERSONS EXCLUDED- Such term does not include any person who is treated as a health information trustee under any other provision of this Act.

(13) LAW ENFORCEMENT INQUIRY- The term `law enforcement inquiry' means an official law enforcement investigation or proceeding inquiring into a violation of, or failure to comply with, any law.

(14) NONIDENTIFIABLE HEALTH INFORMATION- The term `nonidentifiable health information' means information that would be protected health information, except that--

(A) it is impossible to ascertain, based on the information, or on any codes or identifiers related to the information, the identity of any individual whose health or condition is the subject of the information; and

(B) it cannot be linked or matched by a foreseeable method to any other information that pertains to any such individual.

(15) PERSON- The term `person' means any of the following:

(A) An individual.

(B) A government.

(C) A governmental subdivision, agency or authority.

(D) A corporation.

(E) A company.

(F) An association.

(G) A firm.

(H) A partnership.

(I) A society.

(J) An estate.

(K) A trust.

(L) A joint venture.

(M) An individual representative.

(N) Any other legal entity.

(16) PROTECTED HEALTH INFORMATION- The term `protected health information' means any information, including information derived from a biological sample from the human body and demographic information about an individual, whether oral or recorded in any form or medium, that--

(A) is created or received by a health information trustee or an accrediting body;

(B) relates to--

(i) the past, present, or future physical or mental health, predisposition, or condition of an individual, or individuals related by blood to the individual;

(ii) the provision of health care to an individual; or

(iii) the past, present, or future payment for the provision of health care to an individual; and

(C)(i) identifies such individual;

(ii) with respect to which there is a reasonable basis to believe that the information can be used to identify such individual; or

(iii) could be linked or matched by a foreseeable method to any other information which pertains to such individual.

(17) PROTECTED HEALTH INFORMATION SUBFILE- The term `protected health information subfile' means any amount of protected health information which is segregated pursuant to section 201(c).

(18) PUBLIC HEALTH AUTHORITY- The term `public health authority' means an authority or instrumentality of the United States, a State, or a political subdivision of a State that--

(A) is charged by statute with responsibility for public health matters; and

(B) is engaged in such activities as injury reporting, public health surveillance, and public health investigation or intervention.

(19) SECRETARY- The term `Secretary' means the Secretary of Health and Human Services.

(20) STATE- The term `State' includes the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.

(21) WRITING- The term `writing' means writing in either a paper-based or electronic form.

TITLE I--INDIVIDUALS' RIGHTS

Subtitle A--Review of Protected Health Information by Subjects of the Information

SEC. 101. INSPECTION AND COPYING OF PROTECTED HEALTH INFORMATION.

(a) IN GENERAL- Except as provided in subsections (b) and (h), a health information trustee shall permit an individual who is the subject of protected health information, or the individual's designee, to inspect and copy protected health information concerning the individual, including records created under section 102, that the trustee maintains. A health information trustee may require an individual to reimburse the trustee for the reasonable cost of such inspection and copying.

(b) EXCEPTION-

(1) IN GENERAL- A health care provider who is delivering, or has delivered, health care to an individual who is the subject of protected health information relating to such health care is not required by this section to permit inspection or copying of the information, where such inspection or copying reasonably could be expected to endanger the life or physical or mental safety of any individual.

(2) ALTERNATIVE DISCLOSURE- In any case where a health care provider determines that the provider, pursuant to paragraph (1), will not permit an individual to inspect or copy protected health information, the provider may permit inspection or copying by the individual's designee.

(c) DENIAL OF A REQUEST FOR INSPECTION OR COPYING- If a health information trustee denies a request for inspection or copying under subsection (b), the trustee shall inform the individual in writing of--

(1) the reasons for the denial of the request;

(2) any procedures for further review of the denial; and

(3) the individual's right to file with the trustee, if the individual so wishes, a concise statement setting forth the request for inspection or copying.

(d) STATEMENT REGARDING REQUEST- If an individual has filed a statement under subsection (c)(3) setting forth the request, the health information trustee in any subsequent disclosure of the portion of the information requested shall include--

(1) a copy of the individual's statement; and

(2) a concise statement of the reasons for denying the request for inspection or copying.

(e) RULE OF CONSTRUCTION- This section shall not be construed to require a health information trustee to conduct a formal, informal, or other hearing or proceeding concerning a request for inspection or copying of protected health information.

(f) INSPECTION AND COPYING OF SEGREGABLE PORTION- A health information trustee shall permit inspection and copying under subsection (a) of any reasonably segregable portion of a record after deletion of any portion that is exempt under subsection (b).

(g) DEADLINE- A health information trustee shall comply with or deny, in accordance with subsection (c), a request for inspection or copying of protected health information under this section within the 30-day period beginning on the date on which the trustee receives the request.

(h) RULES GOVERNING AGENTS AND CONTRACTORS-

(1) IN GENERAL- A person acting in the capacity of an agent or contractor of a health care provider, health plan, health oversight agency, public health authority, health researcher, employer, insurer, school, institution of higher education, or insurance support organization is not responsible for providing for the inspection or copying of protected health information under this section, except when the agent or contractor has been notified by their principal that a request for inspection or copying has been made to the principal under section (a) and has not been denied under section (b).

(2) CODED HEALTH INFORMATION- In any case where a person acting in the capacity of an agent or contractor of a health care provider, health plan, health oversight agency, public health authority, health researcher, employer, insurer, school, institution of higher education, or insurance support organization is requested to provide for the inspection or copying of coded health information under this section, the person shall inform the individual making the request that the individual should contact a person authorized under section 204 to link or match the coded health information to reveal the identity of the individual who is the subject of the information.

SEC. 102. CORRECTION OR AMENDMENT OF PROTECTED HEALTH INFORMATION.

(a) IN GENERAL- Unless proceeding under subsection (b), and except as provided in subsection (f), a health information trustee, within the 45-day period beginning on the date on which the trustee receives from an individual a written request to correct or amend protected health information about the individual--

(1) shall make the correction or amendment requested;

(2) shall inform the individual of the correction or amendment that has been made; and

(3) shall make reasonable efforts to inform any person who is identified by the individual, and to whom the uncorrected or unamended portion of the information was previously disclosed, of the correction or amendment that has been made.

(b) REFUSAL TO CORRECT OR AMEND- If the health information trustee refuses to make the correction or amendment, the trustee shall inform the individual, within the 45-day period beginning on the date on which the trustee receives the individual's request, of--

(1) the reasons for the refusal to make the correction or amendment;

(2) any procedures for further review of the refusal; and

(3) the individual's right to file with the trustee, if the individual so wishes, a concise statement setting forth the requested correction or amendment and the individual's reasons for disagreeing with the refusal.

(c) STATEMENT OF DISAGREEMENT- If an individual has filed a statement of disagreement under subsection (b)(3), the health information trustee in any subsequent disclosure of the disputed portion of the information--

(1) shall include a copy of the individual's statement; and

(2) shall include a concise statement of the reasons for not making the requested correction or amendment.

(d) RULE OF CONSTRUCTION- This section shall not be construed to require a health information trustee to conduct a formal, informal, or other hearing or proceeding concerning a request for a correction or amendment to protected health information.

(e) CORRECTION- For purposes of subsection (a), a correction is deemed to have been made to protected health information when information that has been disputed by an individual has been corrected, clearly marked as incorrect, or supplemented by correct information.

(f) RULES GOVERNING AGENTS AND CONTRACTORS- A person acting in the capacity of an agent or contractor of a health care provider, health plan, health oversight agency, public health authority, health researcher, employer, insurer, school, institution of higher education, or insurance support organization is not authorized to make corrections or amendments to protected health information received from their principal, except when the agent or contractor has been asked by the principal to fulfill the principal's obligations under this section.

SEC. 103. NOTICE OF INFORMATION PRACTICES.

(a) PREPARATION OF WRITTEN NOTICE- A health information trustee shall prepare and provide, in accordance with subsection (b), a written notice containing the following:

(1) INDIVIDUALS' RIGHTS- A description of the following rights of an individual who is a subject of protected health information maintained by the trustee:

(A) The right of the individual to request segregation of protected health information, and to restrict the use of such information by employees, agents, and contractors of the trustee, under section 201(c).

(B) The right of the individual to inspect, copy, amend, and correct the protected health information under sections 101 and 102.

(C) The right of the individual to object to the disclosure of the information to next of kin or in directory information under section 205.

(D) The circumstances under which the information may be used or disclosed without an authorization executed by the individual.

(E) The right of the individual not to have employment or the receipt of services conditioned upon the execution by the individual of an authorization for disclosure or use for any purpose other than treatment or payment.

(F) The procedures the individual must follow in order to exercise the foregoing rights.

(2) TRUSTEE INFORMATION PRACTICES- A description of the trustee's health information practices, including the safeguards and practices used to protect such information.

(b) AVAILABILITY OF NOTICE TO SUBJECTS- A health information trustee shall provide a copy of a notice prepared under this section to an individual who is a subject of protected health information--

(1) along with any request for authorization to use or disclose the information created pursuant to section 202 or 203 and presented by the trustee to the individual for execution;

(2) at the first practicable opportunity after the trustee uses or discloses the information without an authorization executed by the individual;

(3) at the first practicable opportunity after a health information trustee commences the collection of the information; or

(4) when the individual requests to inspect, copy, correct, or amend their protected health information pursuant to section 101 or 102.

Subtitle B--Establishment of Safeguards

SEC. 111. ESTABLISHMENT OF SAFEGUARDS.

(a) IN GENERAL- A health information trustee shall establish and maintain appropriate administrative, technical, and physical safeguards to ensure the confidentiality, security, accuracy, and integrity of protected health information created, received, obtained, maintained, used or transmitted by the trustee.

(b) SAFEGUARDS FOR ELECTRONIC INFORMATION-

(1) APPLICATION AND CONSTRUCTION-

(A) APPLICATION- This subsection applies only with respect to protected health information that is electronic.

(B) CONSTRUCTION- Nothing in this Act shall be construed to require that protected health information be created, received, maintained, used, or disclosed in electronic form.

(2) REQUIREMENTS FOR ELECTRONIC MAINTENANCE, USE, AND DISCLOSURE- The Secretary shall develop, and by regulation impose on health information trustees, requirements for the electronic maintenance, use, and disclosure of protected health information. Such requirements shall include the following:

(A) CONTROL OF ACCESS TO PROTECTED HEALTH INFORMATION-

(i) IN GENERAL- A health information trustee shall implement controls with respect to access to electronic protected health information. The trustee may grant a request by any person for access to such information for use by the health information trustee, or for disclosure to another

health information trustee, only after verifying that--

(I) the person making the request can prove their identity; and

(II) the proposed use of the protected health information, or the requested disclosure, is authorized under this Act.

(ii) AUTHENTICATION OF IDENTITY OF REQUESTERS- A health information trustee shall use a method of verification to verify the identity of persons requesting access to electronic protected health information. A health information trustee who issues a device that verifies the identity of a person making a request for information for purposes of this clause shall instruct the person in the proper care and use of the device and shall require the person to protect the device from misuse. Any system used by a health information trustee to maintain verification information collected under this clause shall prevent the disclosure of such verification information to any person other than a person who is specifically authorized to receive such information.

(B) ACCESS FOR USE BY HEALTH INFORMATION TRUSTEE- A health information trustee shall limit the persons who may use protected health information created or maintained by the trustee in electronic form to persons specifically authorized by the trustee to use such information consistent with this Act.

(C) DISCLOSURE TO OTHERS-

(i) PROTECTION OF REQUESTS FOR DISCLOSURE AND RESPONSES- A health information trustee who requests, using electronic means, to receive protected health information, or who responds, using electronic means, to such a request, shall implement procedures to prevent the interception of such request or response by persons who are not authorized to intercept it.

(ii) IDENTIFICATION OF SUBJECT- A health information trustee who receives, using electronic means, a request for protected health information from another health information trustee may not provide such information in response to the request unless the request contains sufficient details to uniquely identify one individual who is the subject of the request.

(D) AUDIT TRAIL-

(i) ACCESS TO INFORMATION MAINTAINED BY OTHERS- A health information trustee shall maintain an electronic record concerning each attempt that is made by the trustee, whether authorized or unauthorized, successful or unsuccessful, to access protected health information that is maintained by any other health information trustee in electronic form. The record shall include the identity of the specific individual attempting to gain such access and information sufficient to identify the information sought.

(ii) ACCESS TO INFORMATION MAINTAINED BY THE TRUSTEE- A health information trustee shall maintain an electronic record concerning each attempt that is made by the trustee, or by any other person, whether authorized or unauthorized, successful or unsuccessful, to access protected health information maintained by the trustee in electronic form. The record shall include the identity of the specific individual attempting to gain such access and information sufficient to identify the information sought.

(3) REVIEW OF REQUIREMENTS- The Secretary from time to time shall review the requirements developed and imposed under paragraph (2), to determine whether technological advances or other factors make necessary changes to the requirements. If the Secretary determines that such changes are necessary, the Secretary shall make them.

SEC. 112. ACCOUNTING FOR DISCLOSURES.

(a) IN GENERAL-

(1) PERSONS NOT ACTING AS AGENTS OR CONTRACTORS- Except as provided in paragraph (2), a health information trustee shall create and maintain, with respect to any protected health information disclosure made by the trustee that is not related to treatment, a record of the disclosure in accordance with regulations promulgated by the Secretary.

(2) AGENTS AND CONTRACTORS- A person acting in the capacity of an agent or contractor of a health care provider, health plan, health oversight agency, public health authority, health researcher, employer, insurer, school, institution of higher education, or insurance support organization shall create and maintain, with respect to any protected health information disclosure made by the person that is authorized under one of section 202, 203, 204, or 206 through 213, a record of the disclosure in accordance with regulations promulgated by the Secretary.

(b) RECORD OF DISCLOSURE PART OF PROTECTED HEALTH INFORMATION- A record created and maintained under subsection (a) shall be maintained as protected health information for not less than 7 years.

SEC. 113. PROHIBITION AGAINST RETALIATION.

A health information trustee may not adversely affect another person, directly or indirectly, because such person has exercised a right under this Act, disclosed information relating to a possible violation of this Act, or associated with, or assisted a person in the exercise of a right under this Act.

TITLE II--RESTRICTIONS ON USE AND DISCLOSURE

SEC. 201. GENERAL RULES REGARDING USE AND DISCLOSURE.

(a) GENERAL RULE- A health information trustee may not use or disclose protected health information except as authorized under this title.

(b) SCOPE OF USE AND DISCLOSURE-

(1) COMPATIBILITY WITH PURPOSE FOR OBTAINING INFORMATION- A health information trustee may not use, or disclose to any person, protected health information unless the use or disclosure is compatible with and directly related to--

(A) the purposes for which the information was obtained by the health information trustee; and

(B) in the case where an individual has executed an authorization, for the specific purpose authorized by the individual.

(2) LIMITATION ON AMOUNT OF INFORMATION-

(A) USE AND DISCLOSURE-

(i) IN GENERAL- Every use and disclosure of protected health information by a health information trustee shall be limited to the minimum amount of information necessary to accomplish the purpose for which the information is used or disclosed.

(ii) NONIDENTIFIABLE INFORMATION- A health information trustee shall use and disclose nonidentifiable health information, in lieu of protected health information, to maximum extent possible, consistent with the purpose for the use or disclosure.

(iii) CODED HEALTH INFORMATION- A health information trustee shall use and disclose coded health information, in lieu of any other kind of protected health information, to maximum extent possible, consistent with the purpose for the use or disclosure.

(B) COLLECTION, CREATION, AND REQUESTS- A health information trustee may not collect, create, or request the disclosure of, more protected health information than is necessary to accomplish the purpose for which the information is collected, created, or requested.

(c) SPECIAL RULES FOR PROTECTED HEALTH INFORMATION SUBFILES-

(1) SEGREGATION- A health information trustee shall, upon creating or obtaining protected health information, comply with the request of a subject of such information--

(A) to segregate any amount or type of protected health information; and

(B) to maintain such protected health information as one or more protected health information subfiles.

(2) DISCLOSURE AND USE-

(A) IN GENERAL- Subject to subparagraph (B), a person, other than a health care provider who is otherwise authorized to access or use protected health information about an individual contained in a protected health information subfile for purposes of delivering health care to the individual, may not use or disclose any information that is in the subfile, except as authorized under section 202, 203, or 206.

(B) EMPLOYEES, AGENTS, CONTRACTORS- A health information trustee, with respect to a protected health information subfile created pursuant to paragraph (1), shall limit use of the subfile to those employees, contractors, or agents of the trustee, described by name or job title, who, with respect to the subfile are authorized, pursuant to section 202 or 203, to use or obtain such information.

(C) INFORMATION ON EXISTENCE OF SUBFILES- A health information trustee may not disclose information about the existence of a health information subfile to any person who is not authorized to obtain, access, or use the subfile.

(d) NO GENERAL REQUIREMENT TO DISCLOSE- Nothing in this title that permits a disclosure of protected health information shall be construed to require such disclosure.

(e) LIMITATIONS ON DISCLOSURE AND USE WITHIN A TRUSTEE-

(1) CONDITION OF TREATMENT OR PAYMENT- A health information trustee may not condition delivery of health care, or payment for services, on the receipt of an authorization described in section 202 or 203 that authorizes the disclosure of protected health information to any employee, agent, or contractor who does not perform a legitimate and necessary function with respect to the purpose for which the information was obtained or created.

(2) EMPLOYMENT- A health information trustee may not condition employment on the receipt of an authorization described in section 202 or 203 that authorizes the disclosure of protected health information to any employee, agent, or contractor who does not perform a legitimate and necessary function with respect to the purpose for which the information was obtained or created.

(f) IDENTIFICATION OF DISCLOSED INFORMATION AS PROTECTED INFORMATION- Except as provided in this title, a health information trustee may not disclose protected health information unless such information is clearly identified as protected health information that is subject to this title.

(g) INFORMATION IDENTIFYING PROVIDERS- The Secretary shall issue regulations protecting information identifying health care providers in order to promote the availability of health care services.

(h) USE OF SOCIAL SECURITY NUMBER- A Social Security account number, or a derivative of a Social Security account number, may not be used by a health information trustee for any purpose relating to protected health information or the use or disclosure of such information.

(i) MULTIPLE RECORDS- No person may aggregate, compile, link, or match protected health information held by two or more different health information trustees, or two or more protected health information subfiles pertaining to an individual, without obtaining specific authorization under section 202 or 203 for such use.

(j) NO EFFECT OF AGENCY ON DUTY OR LIABILITY OF PRINCIPAL- An agreement or relationship between a trustee and an agent or contractor does not relieve a health information trustee of any duty or liability under this Act.

SEC. 202. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH INFORMATION FOR TREATMENT OR PAYMENT.

(a) WRITTEN AUTHORIZATIONS- A health information trustee may disclose protected health information for purposes of treatment or payment pursuant to an authorization executed by an individual who is the subject of the information (or a person acting for the individual pursuant to State law) if each of the following requirements is met:

(1) WRITING- The authorization is in written or electronic form, signed or electronically authenticated by the individual, and dated.

(2) SEPARATE FORMS- Separate forms authorizing disclosures for treatment and separate forms authorizing disclosures for payment processes are provided to the individual.

(3) INFORMATION DESCRIBED- The information to be disclosed is specified, or is described, in the authorization.

(4) TRUSTEE DESCRIBED- The trustee who is authorized to disclose such information is specifically identified, or is described, in the authorization.

(5) RECIPIENT DESCRIBED- The person to whom the information is to be disclosed is specifically identified, or is described, in the authorization.

(6) RIGHT TO REVOKE OR AMEND- The authorization contains an acknowledgement that the individual who is executing the authorization has the right to revoke or amend the authorization, subject to subsection (b).

(7) PURPOSE DESCRIBED- The authorization describes in detail the purpose for which the information will be used.

(8) STATEMENT OF INTENDED DISCLOSURES- The authorization contains an acknowledgment that the individual who is executing the authorization has read a statement of any disclosures of the protected health information that the recipient intends to make.

(9) USE AND DISCLOSURE RESTRICTED- The authorization includes a statement that the information will be used and disclosed solely for one or more purposes specified in the authorization.

(10) EXPIRATION DATE SPECIFIED- The authorization specifies a date on which, or event upon which, the authorization expires, which shall be no later than one year after the date on which the authorization is executed.

(b) Revocation or Amendment of Authorization-

(1) IN GENERAL- An authorization under subsection (a) shall be subject to revocation and amendment at any time by the individual who executed the authorization, except that--

(A) the revocation or amendment shall be in writing; and

(B) an authorization executed for the purpose of validation of expenditures for health care that the individual has authorized to be rendered may not be revoked.

(2) NOTICE OF REVOCATION- A health information trustee who discloses protected health information pursuant to an authorization described in subsection (a) that has been revoked shall not be subject to any liability or penalty under this Act if the trustee has no actual or constructive notice of the revocation at the time the trustee makes the disclosure.

(c) MODEL AUTHORIZATIONS- The Secretary, after providing notice and opportunity for public comment, shall develop and disseminate model written authorizations of the type described in subsection (a) and model statements of intended disclosures of the type described in subsection (a)(7).

(d) COPY- A health information trustee who discloses protected health information pursuant to an authorization under this section shall maintain a copy of the authorization for not less than 7 years.

SEC. 203. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH INFORMATION FOR PURPOSES OTHER THAN TREATMENT OR PAYMENT.

(a) WRITTEN AUTHORIZATIONS- A health information trustee may disclose protected health information for a purpose other than treatment or payment pursuant to an authorization executed by an individual who is the subject of the information (or a person acting for the individual pursuant to State law) if each of the following requirements is met:

(1) GENERAL REQUIREMENTS- The requirements of paragraphs (1) through (7) of section 202(a).

(2) STATEMENT OF INTENDED DISCLOSURES- The statement of intended disclosure shall be in writing, and shall be received by the individual authorizing the disclosure on or before the date the authorization is executed.

(3) EXPIRATION DATE SPECIFIED- The authorization specifies a date on which, or an event upon which, the authorization expires, which shall not occur more than 1 year from the date of the execution of the authorization.

(b) LIMITATION ON REQUESTS FOR AUTHORIZATIONS-

(1) CONDITION OF TREATMENT OR PAYMENT- A health information trustee may not condition delivery of treatment, or payment for services, on the receipt of an authorization described in subsection (a).

(2) EMPLOYMENT- A health information trustee may not adversely affect, or condition, the employment of any person based on the agreement or

refusal of the person to execute or provide an authorization described in subsection (a).

(c) REVOCATION OR AMENDMENT OF AUTHORIZATION-

(1) IN GENERAL- An individual may in writing revoke or amend an authorization described in subsection (a).

(2) NOTICE OF REVOCATION- A health information trustee who discloses protected health information pursuant to an authorization described in subsection (a) that has been revoked shall not be subject to any liability or penalty under this Act if the trustee has no actual or constructive notice of the revocation at the time the trustee makes the disclosure.

(d) MODEL AUTHORIZATIONS- The Secretary, after notice and opportunity for public comment, shall develop and disseminate model written authorizations of the type described in subsection (a) and model statements of the intended disclosures of the type described in subsection (a)(2).

SEC. 204. CREATION OF NONIDENTIFIABLE AND CODED INFORMATION.

(a) CREATION OF NONIDENTIFIABLE INFORMATION- A health information trustee may disclose protected health information about an individual to an employee, agent, or contractor for the purpose of creating nonidentifiable health information if--

(1) the individual is informed of the purpose for the creation of the nonidentifiable information;

(2) the individual is given the option to prohibit any specific uses of the nonidentifiable information, such as use of the information for marketing purposes; and

(3) the health information trustee does not condition the delivery of health care, payment for services, or employment, on the granting by the individual of permission to create the nonidentifiable information.

(b) CREATION OF CODED HEALTH INFORMATION- A health care provider may create coded health information, or disclose protected health information about an individual to an employee, agent, or contractor for the purpose of creating coded health information, if--

(1) the individual is informed of the purpose for the creation of the coded information;

(2) the individual is informed of which persons will have the authority to link or match the coded health information to reveal the identity of the individual;

(3) the individual gives written authorization for a disclosure for this purpose in accordance with subsections (a)(1) through (a)(3), (c), and (d) of section 203;

(4) the health care provider does not condition the delivery of health care, payment for services, employment, or the terms of employment on the granting by the individual of permission to create the coded health information; and

(5) agents and contractors who receive protected health information for the purpose of creating coded health information use the information exclusively for such purpose.

SEC. 205. NEXT OF KIN AND DIRECTORY INFORMATION.

(a) NEXT OF KIN- Except as provided in subsection (c), a health care provider, or a person who receives protected health information under section 206, may disclose protected health information regarding an individual who is an inpatient in a health care facility to the individual's next of kin, to an individual representative of the individual, or to an individual with whom the individual has a significant personal relationship if--

(1) the individual who is the subject of the information--

(A) has been notified of the individual's right to object at the time of admission to the facility and has not objected to the disclosure; or

(B) is in a physical or mental condition such that it would not be possible to notify the individual of the right to object and there are no prior indications that the individual would object; and

(2) the information relates to health care currently being provided to the individual at the time of the disclosure.

(b) DIRECTORY INFORMATION-

(1) DISCLOSURE- Except as provided in subsection (c), a health information trustee may disclose to any person protected health information concerning an individual if the information is described in paragraph (2) and the individual who is the subject of the information--

(A) has been notified of the individual's right to object and has not objected to the disclosure; or

(B) is in a physical or mental condition such that it would not be possible to notify the individual of the right to object and there are no prior indications that the individual would object.

(2) INFORMATION DESCRIBED- The information referred to in paragraph (1) is any one or more of the following:

(A) The name of the individual who is the subject of the information.

(B) The general health status of the individual, described as critical, poor, fair, stable, or satisfactory, or in terms denoting similar conditions.

(C) The location of the individual, if on a premises controlled by a health care provider.

(c) EXCEPTION- A health care provider may not disclose protected health information without specific authorization pursuant to section 203--

(1) in the case of a disclosure under subsection (b), if disclosure of the location of the individual would reveal specific information about the physical or mental condition of the individual; or

(2) in the case of a disclosure under subsection (a) or (b), if the provider has reason to believe that the disclosure could lead to physical, mental, or emotional harm to the individual.

(d) Deceased Individual-

(1) IDENTIFICATION- A health information trustee may disclose protected health information if necessary to assist in the identification of a deceased individual.

(2) REGULATIONS- The Secretary shall develop and establish through regulation a procedure for obtaining protected health information relating to a deceased individual when there is no individual representative for such individual.

SEC. 206. EMERGENCY CIRCUMSTANCES.

(a) DISCLOSURE WHEN SUBJECT OF INFORMATION IS IN DANGER- A health information trustee who receives protected health information under this title may disclose such protected health information to a health care provider or emergency medical personnel, or use such information in emergency medical circumstances, to the extent necessary to protect the health or safety of an individual who is a subject of such information from serious imminent harm.

(b) DISCLOSURE WHEN ANOTHER INDIVIDUAL IS IN DANGER- A health information trustee may disclose protected health information, to the extent necessary, where such trustee determines that--

(1) there is an identifiable threat of serious injury or death to an identifiable individual or group of individuals; and

(2) the disclosure of the information to the person is necessary to prevent or significantly reduce the possibility of such threat.

SEC. 207. OVERSIGHT.

(a) IN GENERAL- A health information trustee, other than a public health authority or a health researcher, may disclose protected health information to--

(1) a health oversight agency for any function of the agency authorized by law, if--

(A) there is probable cause to believe fraud has been committed;

(B) the oversight agency is investigating the fraud;

(C) the oversight agency has obtained a subpoena for purposes of obtaining the information; and

(D)(i) a subject of the information is believed to have committed the fraud; or

(ii) the information is necessary to permit the agency to investigate the fraud; or

(2) a health oversight agency charged by law to protect individuals from harm, abuse, neglect, or exploitation, if the information is necessary to investigate whether abuse, neglect, or exploitation of an individual has occurred.

(b) USE OF CODED HEALTH INFORMATION- The health oversight agency shall receive exclusively coded health information under subsection (a) whenever the purpose of the agency may be accomplished using only such information.

(c) NOTICE TO SUBJECTS- In any case where an individual who is a subject of protected health information disclosed under subsection (a) is not believed to have committed fraud, the individual shall be notified, at the first practical opportunity--

(1) that an investigation described in such subsection is being conducted;

(2) of the reason why disclosure of the information is necessary; and

(3) of all intended subsequent disclosures of the information that the agency intends to make.

(d) USE IN ACTION AGAINST INDIVIDUALS-

(1) IN GENERAL- Subject to paragraph (2), protected health information about an individual that is disclosed under this section may not be used in, or disclosed to any person for use in, an administrative, civil, or criminal action or investigation directed against the individual, unless the action or investigation arises out of and is directly related to the purpose for which the disclosure was authorized under subsection (a).

(2) SPECIAL RULE- A health oversight agency may not disclose protected health information received by the agency under subsection (a)(2) for any purpose other than protecting individuals from harm, abuse, neglect, or exploitation.

(e) PUBLIC HEALTH AND HEALTH RESEARCH- A public health authority may disclose protected health information to a health oversight agency only if such information is necessary for use in an investigation of whether the authority has committed fraud. A health researcher may disclose protected health information to a health oversight agency only if such information is necessary for use in an investigation of whether the researcher has committed fraud.

SEC. 208. ACCREDITATION.

(a) IN GENERAL- A health information trustee may disclose protected health information to an accrediting body for the exclusive purpose of permitting the accrediting body to carry out accreditation, licensing, or credentialing activities.

(b) USE OF CODED HEALTH INFORMATION- The accrediting body shall receive exclusively coded health information under subsection (a) whenever the purpose of the body may be accomplished using only such information.

(c) RESTRICTION ON USE AND DISCLOSURE- A person to whom protected health information is disclosed under subsection (a) may not use or disclose the information for any purpose other than the purpose for which the information was disclosed to the person.

SEC. 209. PUBLIC HEALTH.

(a) DISCLOSURES BY PROVIDERS- A health care provider may disclose protected health information about an individual to a public health authority where--

(1) the information is disclosed for the purpose of permitting the authority to ascertain the identity of such individual;

(2) there is a specific nexus between such individual's identity and a threat of death or injury to any person; and

(3) knowledge of such individual's identity would allow the public health authority to prevent or significantly reduce the possibility of injury or death to any person.

(b) LIMITATION ON LIABILITY- A health information trustee shall not be liable to any person for a disclosure of protected health information under this section that is made based upon a good faith belief by the trustee of a representation made by a public health authority that such disclosure satisfies the requirements of subsection (a).

(c) LIMITATION ON USE AND DISCLOSURE BY PUBLIC HEALTH AUTHORITIES- A public health authority may not use or disclose protected health information for any purpose other than for public health reporting, surveillance, protection, investigation, or intervention.

SEC. 210. HEALTH RESEARCH.

(a) IN GENERAL- A health information trustee may disclose protected health information, other than coded health information, to a health researcher for use in a research project engaged in by the health researcher, if an institutional review board, using standards and procedures that are generally consistent with the official written policy of the Secretary with respect to research involving human subjects conducted, supported, or otherwise subject to regulation by Federal departments and agencies, and this Act, determines that the research project--

(1) requires use of the protected health information for the effectiveness of the project and could not be carried out with either coded or nonidentifiable health information; and

(2) has obtained an authorization for the disclosure executed by an individual who is a subject of the information that--

(A) is consistent with the requirements of section 203; and

(B) in a case where the researcher foresees using or disclosing the information for any purpose subsequent to the conclusion of the project, specifically states--

(i) such intent; and

(ii) that the individual has the right to limit such subsequent uses or disclosures consistent with this Act.

(b) USE OF CODED OR NONIDENTIFIABLE HEALTH INFORMATION- A health information trustee may disclose coded health information that is not contained in a protected health information subfile, or nonidentifiable health information, to a health researcher for use in a research project engaged in by the health researcher upon approval of the proposed research by an institutional review board, regardless of whether the researcher has obtained an authorization for the disclosure consistent with the requirements of section 203.

(c) ANONYMIZATION OF PREVIOUSLY STORED BIOLOGICAL SAMPLES- The Secretary may develop interim guidelines for the use by a health researcher of biological samples derived from a human body collected before the effective date of this Act. Such guidelines shall address the requirements pertinent to a health researcher who wishes to use stored biological samples derived from a human body in nonidentifiable or coded form. Such guidelines shall authorize a health researcher, for the purpose of facilitating future health research--

(1) to convert protected health information into nonidentifiable information or coded health information, if such conversion is permitted in a written authorization; or

(2) if no such authorization exists, to make such conversion after publishing notice of the researcher's intent and providing individuals the opportunity to prohibit the use of their biological samples for such purpose.

(d) OBLIGATIONS OF RECIPIENT- A person who receives protected health information pursuant to subsection (a)--

(1) shall remove or destroy, at the earliest opportunity consistent with the purposes of the project, information that would enable an individual to be identified, unless--

(A) an institutional review board has determined that there is a health or research justification for retention of such identifiers; and

(B) there is an adequate plan to protect the identifiers from disclosure that is inconsistent with this section; and

(2) shall use the information solely for purposes of the health research project for which disclosure was authorized by an institutional review board under subsection (a).

SEC. 211. JUDICIAL AND ADMINISTRATIVE PURPOSES.

A health care provider, health plan, health oversight agency, employer, school, institution of higher education, insurer, court, or a person who receives protected health information pursuant to section 206 may disclose protected health information about an individual--

(1) pursuant to the requirements governing subpoenas, warrants, and court orders under sections 212 and 213, where such information has been determined to be discoverable by a court under any applicable rules of civil or criminal procedure;

(2) to a court, and to others as ordered by the court, if the information is developed in response to a court-ordered physical or mental examination;

(3) where the subject of such information has brought a claim for medical malpractice against a health care provider and the information is necessary for the defense of the claim; and

(4) to legal counsel for the person making the disclosure, where the disclosure is necessary to ensure compliance with this Act or any other legal requirement.

SEC. 212. GENERAL REQUIREMENTS GOVERNING SUBPOENAS.

(a) IN GENERAL- A health care provider, health plan, health oversight agency, employer, school, institution of higher education, insurer, court, or a person who receives protected health information pursuant to section 206 may disclose protected health information to any person, other than a law enforcement authority, under section 211(1), if the disclosure is pursuant to a subpoena issued on behalf of a party to a lawsuit or other judicial or administrative proceeding who has complied with subsection (b) or (c), and subsection (d).

(b) REQUEST FOR ACCESS BY COUNSEL TO REVIEW PROTECTED HEALTH INFORMATION- A person may have

access to protected health information under subsection (a), by means solely of a review of the information by the person's counsel, acting in the capacity of an officer of the court, and on premises of, and under the control of, the court, if--

(1) the person has included in a subpoena a proffer of evidence specifying with reasonable specificity the information to which access is sought and the precise grounds for seeking such access for review;

(2) a copy of such subpoena for access to review, together with a notice of the individual's right to challenge the subpoena under subsection (d), has been served upon the individual on or before the date of return of the subpoena;

(3)(A) 15 days have passed since the date of service on the individual, and within that period the individual has not initiated a challenge in accordance with subsection (d)(1); or

(B) such access is ordered by the court; and

(4) such counsel agrees not to copy such information, remove such information from the court premises, or disclose the information to any person other than the person permitted access under this subsection.

(c) REQUEST TO OBTAIN PROTECTED HEALTH INFORMATION FOR INTRODUCTION IN COURT-

(1) REQUIREMENTS FOR OBTAINING INFORMATION- A person may obtain protected health information about an individual pursuant to a subpoena, for purposes of introducing such information as evidence in a court, only if--

(A) counsel for the person has obtained access to the information under subsection (b);

(B) a copy of the subpoena to obtain the information for introduction in court, specifying the precise information sought and the precise grounds for seeking introduction of the information as evidence in court, together with a notice of the individual's right to challenge the subpoena under subsection (d), has been served upon the individual on or before the date of return of such subpoena; and

(C)(i) 15 days have passed since the date of service on the individual, and within that time period the individual has not indicated a challenge in accordance with subsection (d)(1); or

(ii) the information is ordered to be provided to the court.

(2) USE AND DISCLOSURE- A person who obtains protected health information under paragraph (1) may use and disclose such information only for the purpose of prosecuting or defending the lawsuit or other judicial or administrative proceeding described in subsection (a).

(d) CHALLENGE PROCEDURES-

(1) MOTION TO QUASH SUBPOENA- After being served of a copy of a subpoena seeking access for review by counsel of, or access to, protected health information under subsection (b), or a subpoena seeking to obtain protected health information for introduction as evidence in court, under subsection (c), an individual who is a subject of such information may file in any court of competent jurisdiction a motion to quash the subpoena.

(2) STANDARD FOR DECISION-

(A) IN GENERAL- The court shall grant a motion under paragraph (1) unless the respondent demonstrates--

(i) by clear and convincing evidence that the information is necessary in relation to the lawsuit or other judicial or administrative proceeding with respect to which the information is sought, including--

(I) a demonstration that use or disclosure of solely nonidentifiable health information would be insufficient to accomplish the purpose for which the information is sought; and

(II) if protected health information that is not coded health information is sought, a demonstration that use or disclosure of coded health information would be insufficient to accomplish the purpose for which the information is sought; and

(ii) that the need of the respondent for the information outweighs the privacy interest of the individual.

(B) CRITERIA FOR DECISION- In determining whether the need of the respondent for the information outweighs the privacy interest of the individual, the court shall consider--

(i) the particular purpose for which the information was collected;

(ii) the invasion of the individual's privacy caused by the disclosure;

(iii) the degree to which disclosure of the information would embarrass, injure, or further invade, the privacy of the individual;

(iv) the effect of the disclosure on the individual's future health care;

(v) the importance of the information to the lawsuit or proceeding; and

(vi) any other relevant factor.

(3) ATTORNEY'S FEES- In the case of a motion brought under paragraph (1) in which the individual who brought the motion has prevailed in whole or in part, the court may assess against the respondent a reasonable attorney's fee and other litigation costs and expenses (including expert fees) reasonably incurred.

(e) SEALING OF INFORMATION- Any portion of a record of a court that contains protected health information disclosed under this section shall be kept by the court under seal and used or disclosed only pursuant to an order of the court consistent with this section.

SEC. 213. ADDITIONAL REQUIREMENTS FOR LAW ENFORCEMENT ACCESS.

(a) LAW ENFORCEMENT SUBPOENAS AND WARRANTS IN GENERAL- A health care provider, health plan,

health oversight agency, employer, school, institution of higher education, insurer, court, or a person who receives protected health information pursuant to section 206 may disclose protected health information to a law enforcement authority under section 211(1), if--

(1)(A) the disclosure is made pursuant to a subpoena for review under section 212(b), a subpoena for purposes of introducing evidence in a court under section 212(c), or both, issued under the authority of a grand jury or a court; and

(B) the requirements of subsections (b) through (e) of section 212, and subsections (b) and (c) of this section, are satisfied;

(2) the disclosure is made pursuant to a judicial warrant for search and seizure and the requirements of subsection (d) are satisfied; or

(3)(A) the disclosure is made pursuant to a subpoena for purposes of introducing evidence in a court under section 212(c), issued under the authority of a grand jury or a court, and obtained pursuant to subsection (d)(5) following the execution of a judicial warrant for search and seizure under subsection (d); and

(B) the requirements of subsections (c) through (e) (other than subsection (c)(1)(A)) of section 212, and subsections (b) and (c) of this section, are satisfied.

(b) CLEAR AND CONVINCING REQUIREMENT- A law enforcement authority may not obtain protected health information about an individual under subsection (a) unless the authority demonstrates by clear and convincing evidence that the information is necessary to a legitimate law enforcement inquiry into a particular violation of criminal law being conducted by the authority.

(c) LIMITATION ON USE AND DISCLOSURE FOR OTHER LAW ENFORCEMENT INQUIRIES- Protected health information about an individual that is disclosed under this section may not be used in, or disclosed to any person for use in, any administrative, civil, or criminal action or investigation directed against the individual, unless the action or investigation arises out of, or is directly related to, the law enforcement inquiry for which the information was obtained.

(d) REQUIREMENTS FOR WARRANTS FOR SEARCH AND SEIZURE-

(1) LIMITED PURPOSE- A health care provider, health plan, health oversight agency, employer, school, institution of higher education, insurer, or a person who receives protected health information pursuant to section 206 may disclose protected health information to a law enforcement authority pursuant to a warrant for search and seizure, issued under the authority of a court, for the exclusive purpose of permitting the authority to secure the information described in the warrant for delivery to the court.

(2) LIMITATION ON EXECUTION OF WARRANTS- In executing a warrant under paragraph (1), a law enforcement authority shall engage in the most minimal examination of protected health information that is necessary in order to determine whether the information is or is not within the scope of the warrant. The authority immediately shall place any such information that the authority determines is within the scope of the warrant under seal, and shall deliver such sealed information, without any further examination or other use or disclosure, to the court. The authority may not use or disclose for any purpose protected health information that the authority determines is not within the scope of the warrant, but that is obtained or discovered by the authority directly or indirectly through execution of the warrant.

(3) NOTICE OF WARRANT- A law enforcement authority that obtains protected health information about an individual pursuant to the execution of a warrant under paragraph (2) shall, not later than 30 days after the date of such execution, serve the individual with, or mail to the last known address of the individual, a notice that protected health information about the individual was obtained, together with a notice of the individual's right to challenge the warrant under paragraph (4).

(4) CHALLENGE PROCEDURES FOR WARRANTS-

(A) MOTION TO QUASH- Within 15 days after the date of service of a notice of execution of a warrant of a law enforcement authority seeking protected health information about an individual under paragraph (3), the individual (or any other person who was in possession of the information and against whom the warrant was executed) may file in any court of competent jurisdiction a motion to quash the warrant.

(B) STANDARD FOR DECISION- The court shall grant a motion under subparagraph (A) unless the law enforcement authority demonstrates by clear and convincing evidence that the protected health information is necessary to a legitimate law enforcement inquiry being conducted by the law enforcement authority and the government authority's need for the information outweighs the privacy interest of the individual.

(C) ATTORNEY'S FEES- In the case of a motion brought under subparagraph (A) in which the individual has prevailed, in whole or in part, the court may assess against the law enforcement authority reasonable attorney's fees and other litigation costs (including expert fees) reasonably incurred.

(5) ACTION IN COURT ON INFORMATION DELIVERED- Upon termination of the period described in paragraph (4)(A) (in a case where a motion to quash is not filed under such paragraph), or upon the denial of a motion to quash under such paragraph, the law enforcement authority may obtain protected health information delivered to the court under this subsection solely through a disclosure under subsection (a)(3).

(6) SEALING OF INFORMATION- Any protected health information that is delivered to a court under this section shall be kept by the court under seal and

used or disclosed only pursuant to an order of the court consistent with this section.

TITLE III--SANCTIONS

Subtitle A--Civil Sanctions

SEC. 301. CIVIL PENALTY.

(a) VIOLATION- Any person who the Secretary determines has materially failed to comply with this Act shall be subject, in addition to any other penalties that may be prescribed by law, to--

(1) a civil penalty of not more than $25,000 for each such violation, but not to exceed $150,000 in the aggregate for multiple violations in any one year; and

(2) a civil penalty of not more than $500,000 and exclusion from participation in the program under title XVIII of the Social Security Act, the program under title XIX of such Act, and any other federally funded health care program, if the Secretary finds that such violations have occurred with such frequency as to constitute a general business practice.

(b) PROCEDURES FOR IMPOSITION OF PENALTIES- Section 1128A of the Social Security Act, other than subsections (a) and (b) and the second sentence of subsection (f) of that section, shall apply to the imposition of a civil, monetary, or exclusionary penalty under this section in the same manner as such provisions apply with respect to the imposition of a penalty under section 1128A of such Act.

SEC. 302. CIVIL ACTION.

(a) IN GENERAL- An individual who is aggrieved by conduct in violation of this Act may bring a civil action to recover--

(1) such preliminary and equitable relief as the court determines to be appropriate;

(2) the greater of--

(A) actual damages; and

(B) liquidated damages of--

(i) $25,000, in the case of a material violation; or

(ii) $50,000, in the case of a violation that was willful or resulted in profit or monetary gain; and

(3) punitive damages.

(b) ATTORNEY'S FEES- In the case of a civil action brought under subsection (a) in which the individual has substantially prevailed, the court may assess against the respondent a reasonable attorney's fee and other litigation costs and expenses (including expert fees) reasonably incurred.

(c) LIMITATION- No action may be commenced under this section by an individual more than 3 years after the date on which the violation was or should reasonably have been discovered by the individual.

Subtitle B--Criminal Sanctions

SEC. 311. WRONGFUL DISCLOSURE OF PROTECTED HEALTH INFORMATION.

(a) OFFENSE- Whoever knowingly--

(1) obtains protected health information relating to an individual in violation of this Act;

(2) discloses protected health information to another person in violation of this Act;

(3) coerces or attempts to coerce a health information trustee to disclose protected health information in violation of this title; or

(4) without authorization pursuant to this Act, identifies or attempts to identify an individual who is the subject of protected health information that a health information trustee has converted into coded health information,

shall be punished as provided in subsection (b).

(b) PENALTIES- A person referred to in subsection (a) shall be fined under title 18, United States Code, imprisoned not more than 1 year, or both, except that--

(1) if the offense is committed under false pretenses, the person shall be fined under title 18, United States Code, imprisoned not more than 5 years, or excluded from participation in the program under title XVIII of the Social Security Act, the program under title XIX of such Act, or any other federally funded health care program, or any combination of such penalties; and

(2) if the offense is committed with intent to sell, transfer, or use protected health information for commercial advantage, personal gain, or malicious harm, the person shall be fined under title 18, United States Code, or imprisoned not more than 10 years, or excluded from participation in the program under title XVIII of the Social Security Act, the program under title XIX of such Act, or any other federally funded health care program, or any combination of such penalties.

TITLE IV--MISCELLANEOUS

SEC. 401. REGULATIONS.

(a) PROMULGATION-

(1) CONSULTATION WITH ADVISORY GROUP- In promulgating regulations under this Act, the Secretary shall appoint and consult an advisory group of knowledgeable individuals.

(2) MEMBERSHIP- The advisory group shall consist of at least 7 but no more than 12 individuals, including representatives of--

(A) health care providers;

(B) health care consumers;

(C) health plans;

(D) privacy advocates; and

(E) electronic security experts.

(3) RESPONSIBILITIES- The advisory group shall review all proposed rules and regulations and submit recommendations to the Secretary. The advisory group shall also assist the Secretary in establishing the standards for compliance with rules and regulations, in developing an annual report to the Congress on the status of the requirements set forth in this Act, their cost impact, and any recommendations for modifications to this Act in order to ensure efficient and confidential electronic interchange of protected health information.

(b) CONSULTATION WITH OTHERS- In promulgating regulations under this Act, the Secretary may consult--

(1) privacy, industry, health care professional, and consumer groups;

(2) medical societies; and

(3) academic computer security and privacy experts.

SEC. 402. RELATIONSHIP TO OTHER LAWS.

(a) IN GENERAL- Nothing in this Act shall be construed to preempt any provision of State law or any privilege, whether derived from statute or common law, that--

(1) more completely protects the confidentiality or privacy of an individual with respect to protected health information about the individual than does this Act; or

(2) provides a greater right of access to protected health information to a subject of the information than does this Act.

(b) CRIMINAL PENALTIES- A State may establish and enforce criminal penalties with respect to a failure to comply with a provision of this Act.

(c) PRIVILEGES- This Act does not preempt or modify State common or statutory law to the extent such law concerns a privilege of a witness or person in a court of the State. This Act does not supersede or modify Federal common or statutory law to the extent such law concerns a privilege of a witness or person in a court of the United States and more completely protects the confidentiality or privacy of an individual with respect to protected health information about the individual than does this Act. The execution of an authorization pursuant to section 202 or 203 may not be construed as a waiver of any such privilege.

(d) CERTAIN DUTIES UNDER STATE OR FEDERAL LAW- This Act does not preempt, supersede, or modify the operation of any of the following:

(1) Any law that provides for the reporting of vital statistics such as birth or death information.

(2) Any law requiring the reporting of abuse or neglect information about any individual.

(3) Any State law relating to public or mental health that prevents or otherwise restricts disclosure of protected health information otherwise permitted under this Act.

(4) Subpart II of part E of title XXVI of the Public Health Service Act (relating to notifications of emergency response employees of possible exposure to infectious diseases).

(5) Any Federal law or regulation governing confidentiality of alcohol and drug patient records.

(6) The Americans With Disabilities Act of 1990.

(7) Any Federal or State statute that establishes a privilege for records used in health professional peer review activities.

SEC. 403. EFFECTIVE DATES.

(a) IN GENERAL- Except as provided in subsection (b), this Act shall take effect on the date that is 18 months after the date of the enactment of this Act.

(b) PROVISIONS EFFECTIVE IMMEDIATELY- A provision of this Act shall take effect on the date of the enactment of this Act if the provision imposes on the Secretary a duty to develop, establish, or promulgate regulations, guidelines, or model forms.

(c) DEADLINE FOR REGULATIONS- The Secretary shall promulgate regulations implementing this Act not later than the date that is 12 months after the date of the enactment of this Act.

SEC. 404. APPLICABILITY.

(a) PROTECTED HEALTH INFORMATION- Except as provided in subsection (b), the provisions of this Act shall apply to any protected health information that is received, created, used, maintained, or disclosed by a health information trustee on or after the date that is 18 months after the date of the enactment of this Act, regardless of whether the information existed or was disclosed prior to such date.

(b) AUTHORIZATIONS FOR DISCLOSURES- An authorization for the disclosure of protected health information about a protected individual that is executed by the individual before the date that is 18 months after the date of the enactment of this Act, and is recognized and valid under State law on the day before such date, shall remain valid and shall not be subject to the requirements of title II until the date that is 30 months after the date of the enactment of this Act, or the occurrence of the date or event in the authorization upon which the authorization expires, whichever occurs earlier.

END