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1 | AN ACT concerning medical privacy.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 1. Short title. This Act may be cited as the | ||||||||||||||||||||||||||
5 | Prescription Record Privacy Act. | ||||||||||||||||||||||||||
6 | Section 5. Purpose. It is the intent of the General | ||||||||||||||||||||||||||
7 | Assembly to safeguard the confidentiality of prescribing
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8 | information, protect the integrity of the doctor-patient | ||||||||||||||||||||||||||
9 | relationship, maintain the
integrity and public trust in the | ||||||||||||||||||||||||||
10 | medical profession, combat vexatious and harassing
sales | ||||||||||||||||||||||||||
11 | practices, restrain undue influence exerted by pharmaceutical | ||||||||||||||||||||||||||
12 | industry
marketing representatives over prescribing decisions | ||||||||||||||||||||||||||
13 | and further the State interest
in improving the quality and | ||||||||||||||||||||||||||
14 | lowering the cost of health care. The General Assembly
intends | ||||||||||||||||||||||||||
15 | to regulate the monitoring of prescribing practices only for | ||||||||||||||||||||||||||
16 | commercial
marketing purposes by companies selling prescribed | ||||||||||||||||||||||||||
17 | products. The intent is not to
regulate monitoring for other | ||||||||||||||||||||||||||
18 | uses, such as quality control, research unrelated to
marketing, | ||||||||||||||||||||||||||
19 | or use by governments or other entities not in the business of | ||||||||||||||||||||||||||
20 | selling
health care products.
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21 | Section 10. Definitions. For the purposes of this Act: | ||||||||||||||||||||||||||
22 | "Bona fide clinical trial" means any research project that |
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1 | prospectively
assigns human subjects to intervention and | ||||||
2 | comparison groups to study the
cause and effect relationship | ||||||
3 | between a medical intervention and a health
outcome, has | ||||||
4 | received approval from an appropriate Institutional Review
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5 | Board, and has been registered at the website | ||||||
6 | "ClinicalTrials.Gov" prior to commencement.
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7 | "Department" means the Illinois Department of Public | ||||||
8 | Health. | ||||||
9 | "Individual identifying information" means information | ||||||
10 | that directly or
indirectly identifies a prescriber or a | ||||||
11 | patient in the State, where the
information is derived from or | ||||||
12 | relates to a prescription for any prescribed
product.
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13 | "Marketing" means any activity by a company making or | ||||||
14 | selling
prescribed products, or such company's agent, intended | ||||||
15 | to influence
prescribing or purchasing choices of its products, | ||||||
16 | including, but not limited to: | ||||||
17 | (1) advertising, publicizing, promoting or sharing | ||||||
18 | information about a
product;
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19 | (2) identifying individuals to receive a message | ||||||
20 | promoting use of a
particular product, including but not | ||||||
21 | limited to an advertisement,
brochure, or contact by a | ||||||
22 | sales representative;
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23 | (3) planning the substance of a sales representative | ||||||
24 | visit or
communication or the substance of an advertisement | ||||||
25 | or other
promotional message or document;
| ||||||
26 | (4) evaluating or compensating sales representatives; |
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1 | (5) identifying individuals to receive any form of | ||||||
2 | gift, product sample,
consultancy, or any other item, | ||||||
3 | service, compensation or employment
of value;
or | ||||||
4 | (6) advertising or promoting prescribed products | ||||||
5 | directly to patients. | ||||||
6 | (d) "Person" means a business, individual, corporation, | ||||||
7 | union, association,
firm, partnership, committee, or other | ||||||
8 | organization or group of persons.
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9 | (e) "Pharmacy" means any individual or entity licensed | ||||||
10 | under State law to
dispense prescribed products.
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11 | (f) "Prescribed product" includes a biological product as | ||||||
12 | defined in Section
351 of the Public Health Service Act, 42 | ||||||
13 | U.S.C. §262 and a device or a drug
as defined in Section 201 of | ||||||
14 | the Federal Food, Drug and Cosmetic Act, 21
U.S.C. §321.
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15 | (g) "Regulated record" means information or documentation | ||||||
16 | from a
prescription written by a prescriber doing business in | ||||||
17 | this State or a
prescription dispensed in the State.
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18 | (h) "State health care program" means a program for which | ||||||
19 | the State purchases
prescribed products, including, but not | ||||||
20 | limited to, a State pharmaceutical
assistance program, or a | ||||||
21 | program for State employees and their dependants,
individuals | ||||||
22 | under the supervision of the Department of Corrections, or | ||||||
23 | State retirees and their
dependants, with the exception of the | ||||||
24 | State medical assistance program
(Medicaid).
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25 | Section 15. Privacy provisions. |
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1 | (a) No person shall knowingly disclose or use regulated | ||||||
2 | records in the State that
include prescription information | ||||||
3 | containing individual identifying information for
marketing a | ||||||
4 | prescribed product.
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5 | (b) A regulated record containing individual identifying | ||||||
6 | information may be
transferred to another entity, including | ||||||
7 | another branch or subsidiary of the
same firm, only if the | ||||||
8 | sender has received satisfactory assurance from the recipient | ||||||
9 | that he or she will
safeguard the records from being disclosed | ||||||
10 | or used in the State for a marketing
purpose prohibited under | ||||||
11 | this Section.
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12 | (c) Regulated records containing individual identifying | ||||||
13 | information may be
disclosed, sold, transferred, exchanged, or | ||||||
14 | used for non-marketing purposes.
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15 | (d) This Section does not prohibit conduct involving the | ||||||
16 | collection, use, transfer,
or sale of regulated records for | ||||||
17 | marketing purposes if:
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18 | (1) the data is aggregated; | ||||||
19 | (2) the data does not contain individually identifying | ||||||
20 | information; and | ||||||
21 | (3) there is no reasonable basis to believe that the | ||||||
22 | data can be used to
obtain individually identifying | ||||||
23 | information.
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24 | (e) This Section does not prevent any person from | ||||||
25 | disclosing regulated records to
the identified individual as | ||||||
26 | long as the information does not include protected
information |
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1 | pertaining to any other person.
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2 | (f) The Department may adopt rules as necessary to | ||||||
3 | implement this Act. | ||||||
4 | Section 20. Enforcement. | ||||||
5 | (a) Any person who knowingly fails to comply with the | ||||||
6 | requirements of this Act
or rules adopted pursuant to this Act | ||||||
7 | by using or disclosing regulated
records in a manner not | ||||||
8 | authorized by this Act or its rules shall be subject to
an | ||||||
9 | administrative penalty of at least $10,000 per violation and | ||||||
10 | not more than
$50,000 per violation, as assessed by the | ||||||
11 | Department. Each disclosure of a
regulated record shall | ||||||
12 | constitute a violation. The office of the State Attorney | ||||||
13 | General
shall take necessary action to enforce payment of | ||||||
14 | penalties assessed under this
Section. Minimum statutory | ||||||
15 | penalties shall be set at $10,000 per violation.
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16 | (b) In addition to any other remedy provided by law, a | ||||||
17 | violation of this Act shall
be an unfair or deceptive act in | ||||||
18 | trade or commerce and an unfair method of
competition and may | ||||||
19 | be enforced through the Consumer Fraud and Deceptive Business | ||||||
20 | Practices Act.
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21 | Section 25. Severability. If any provision of this Act or | ||||||
22 | its application to any person or circumstance is held
invalid, | ||||||
23 | the remainder of the Act or the application of the provision to | ||||||
24 | other persons
or circumstances is not affected.
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1 | Section 30. No extra-territorial effect. Nothing in this | ||||||
2 | bill shall be interpreted to regulate conduct that takes place | ||||||
3 | entirely
outside of the State.
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4 | Section 35. No effect on truthful speech to doctors or | ||||||
5 | patients. Nothing in this Act shall be interpreted to regulate | ||||||
6 | the content, time, place or
manner of any discussion between a | ||||||
7 | prescriber and his or her patient, or a prescriber
and any | ||||||
8 | person representing a prescription drug manufacturer.
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9 | Section 40. The Consumer Fraud and Deceptive Business | ||||||
10 | Practices Act is amended by changing Section 2Z as follows:
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11 | (815 ILCS 505/2Z) (from Ch. 121 1/2, par. 262Z)
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12 | Sec. 2Z. Violations of other Acts. Any person who knowingly | ||||||
13 | violates
the Automotive Repair Act, the Automotive Collision | ||||||
14 | Repair Act,
the Home Repair and Remodeling Act,
the Dance | ||||||
15 | Studio Act,
the Physical Fitness Services Act,
the Hearing | ||||||
16 | Instrument Consumer Protection Act,
the Illinois Union Label | ||||||
17 | Act,
the Job Referral and Job Listing Services Consumer | ||||||
18 | Protection Act,
the Travel Promotion Consumer Protection Act,
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19 | the Credit Services Organizations Act,
the Automatic Telephone | ||||||
20 | Dialers Act,
the Pay-Per-Call Services Consumer Protection | ||||||
21 | Act,
the Telephone Solicitations Act,
the Illinois Funeral or | ||||||
22 | Burial Funds Act,
the Cemetery Care Act,
the Safe and Hygienic |
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1 | Bed Act,
the Pre-Need Cemetery Sales Act,
the High Risk Home | ||||||
2 | Loan Act, the Payday Loan Reform Act, the Mortgage Rescue Fraud | ||||||
3 | Act, subsection (a) or (b) of Section 3-10 of the
Cigarette Tax | ||||||
4 | Act, the Payday Loan Reform Act, subsection
(a) or (b) of | ||||||
5 | Section 3-10 of the Cigarette Use Tax Act, the Electronic
Mail | ||||||
6 | Act, the Internet Caller Identification Act, paragraph (6)
of
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7 | subsection (k) of Section 6-305 of the Illinois Vehicle Code, | ||||||
8 | Section 18d-115, 18d-120, 18d-125, 18d-135, or 18d-150 of the | ||||||
9 | Illinois Vehicle Code, Article 3 of the Residential Real | ||||||
10 | Property Disclosure Act, the Automatic Contract Renewal Act, or | ||||||
11 | the Personal Information Protection Act , or the Prescription | ||||||
12 | Record Privacy Act commits an unlawful practice within the | ||||||
13 | meaning of this Act.
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14 | (Source: P.A. 94-13, eff. 12-6-05; 94-36, eff. 1-1-06; 94-280, | ||||||
15 | eff. 1-1-06; 94-292, eff. 1-1-06; 94-822, eff. 1-1-07; 95-413, | ||||||
16 | eff. 1-1-08; 95-562, eff. 7-1-08; 95-876, eff. 8-21-08.)
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17 | Section 99. Effective date. This Act takes effect upon | ||||||
18 | becoming law.
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