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1 AN ACT concerning regulation.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Pharmacy Practice Act is amended by
5 changing Section 3 as follows:
6 (225 ILCS 85/3)
7 (Section scheduled to be repealed on January 1, 2028)
8 Sec. 3. Definitions. For the purpose of this Act, except
9 where otherwise limited therein:
10 (a) "Pharmacy" or "drugstore" means and includes every
11 store, shop, pharmacy department, or other place where
12 pharmacist care is provided by a pharmacist (1) where drugs,
13 medicines, or poisons are dispensed, sold or offered for sale
14 at retail, or displayed for sale at retail; or (2) where
15 prescriptions of physicians, dentists, advanced practice
16 registered nurses, physician assistants, veterinarians,
17 podiatric physicians, or optometrists, within the limits of
18 their licenses, are compounded, filled, or dispensed; or (3)
19 which has upon it or displayed within it, or affixed to or used
20 in connection with it, a sign bearing the word or words
21 "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
22 "Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
23 "Drugs", "Dispensary", "Medicines", or any word or words of
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1 similar or like import, either in the English language or any
2 other language; or (4) where the characteristic prescription
3 sign (Rx) or similar design is exhibited; or (5) any store, or
4 shop, or other place with respect to which any of the above
5 words, objects, signs or designs are used in any
6 advertisement.
7 (b) "Drugs" means and includes (1) articles recognized in
8 the official United States Pharmacopoeia/National Formulary
9 (USP/NF), or any supplement thereto and being intended for and
10 having for their main use the diagnosis, cure, mitigation,
11 treatment or prevention of disease in man or other animals, as
12 approved by the United States Food and Drug Administration,
13 but does not include devices or their components, parts, or
14 accessories; and (2) all other articles intended for and
15 having for their main use the diagnosis, cure, mitigation,
16 treatment or prevention of disease in man or other animals, as
17 approved by the United States Food and Drug Administration,
18 but does not include devices or their components, parts, or
19 accessories; and (3) articles (other than food) having for
20 their main use and intended to affect the structure or any
21 function of the body of man or other animals; and (4) articles
22 having for their main use and intended for use as a component
23 or any articles specified in clause (1), (2) or (3); but does
24 not include devices or their components, parts or accessories.
25 (c) "Medicines" means and includes all drugs intended for
26 human or veterinary use approved by the United States Food and
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1 Drug Administration.
2 (d) "Practice of pharmacy" means:
3 (1) the interpretation and the provision of assistance
4 in the monitoring, evaluation, and implementation of
5 prescription drug orders;
6 (2) the dispensing of prescription drug orders;
7 (3) participation in drug and device selection;
8 (4) drug administration limited to the administration
9 of oral, topical, injectable, and inhalation as follows:
10 (A) in the context of patient education on the
11 proper use or delivery of medications;
12 (B) vaccination of patients 7 years of age and
13 older pursuant to a valid prescription or standing
14 order, by a physician licensed to practice medicine in
15 all its branches, except for vaccinations covered by
16 paragraph (15), upon completion of appropriate
17 training, including how to address contraindications
18 and adverse reactions set forth by rule, with
19 notification to the patient's physician and
20 appropriate record retention, or pursuant to hospital
21 pharmacy and therapeutics committee policies and
22 procedures. Eligible vaccines are those listed on the
23 U.S. Centers for Disease Control and Prevention (CDC)
24 Recommended Immunization Schedule, the CDC's Health
25 Information for International Travel, or the U.S. Food
26 and Drug Administration's Vaccines Licensed and
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1 Authorized for Use in the United States. As applicable
2 to the State's Medicaid program and other payers,
3 vaccines ordered and administered in accordance with
4 this subsection shall be covered and reimbursed at no
5 less than the rate that the vaccine is reimbursed when
6 ordered and administered by a physician;
7 (B-5) (blank); following the initial
8 administration of long-acting or extended-release form
9 opioid antagonists by a physician licensed to practice
10 medicine in all its branches, administration of
11 injections of long-acting or extended-release form
12 opioid antagonists for the treatment of substance use
13 disorder, pursuant to a valid prescription by a
14 physician licensed to practice medicine in all its
15 branches, upon completion of appropriate training,
16 including how to address contraindications and adverse
17 reactions, including, but not limited to, respiratory
18 depression and the performance of cardiopulmonary
19 resuscitation, set forth by rule, with notification to
20 the patient's physician and appropriate record
21 retention, or pursuant to hospital pharmacy and
22 therapeutics committee policies and procedures;
23 (C) administration of injections of
24 alpha-hydroxyprogesterone caproate, pursuant to a
25 valid prescription, by a physician licensed to
26 practice medicine in all its branches, upon completion
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1 of appropriate training, including how to address
2 contraindications and adverse reactions set forth by
3 rule, with notification to the patient's physician and
4 appropriate record retention, or pursuant to hospital
5 pharmacy and therapeutics committee policies and
6 procedures; and
7 (D) administration of long-acting injectables for
8 mental health or substance use disorders injections of
9 long-term antipsychotic medications pursuant to a
10 valid prescription by the patient's a physician
11 licensed to practice medicine in all its branches,
12 advanced practice registered nurse, or physician
13 assistant upon completion of appropriate training
14 conducted by an Accreditation Council of
15 Pharmaceutical Education accredited provider,
16 including how to address contraindications and adverse
17 reactions set forth by rule, with notification to the
18 patient's physician and appropriate record retention,
19 or pursuant to hospital pharmacy and therapeutics
20 committee policies and procedures; .
21 (5) (blank);
22 (6) drug regimen review;
23 (7) drug or drug-related research;
24 (8) the provision of patient counseling;
25 (9) the practice of telepharmacy;
26 (10) the provision of those acts or services necessary
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1 to provide pharmacist care;
2 (11) medication therapy management;
3 (12) the responsibility for compounding and labeling
4 of drugs and devices (except labeling by a manufacturer,
5 repackager, or distributor of non-prescription drugs and
6 commercially packaged legend drugs and devices), proper
7 and safe storage of drugs and devices, and maintenance of
8 required records;
9 (13) the assessment and consultation of patients and
10 dispensing of hormonal contraceptives;
11 (14) the initiation, dispensing, or administration of
12 drugs, laboratory tests, assessments, referrals, and
13 consultations for human immunodeficiency virus
14 pre-exposure prophylaxis and human immunodeficiency virus
15 post-exposure prophylaxis under Section 43.5;
16 (15) vaccination of patients 7 years of age and older
17 for COVID-19 or influenza subcutaneously, intramuscularly,
18 or orally as authorized, approved, or licensed by the
19 United States Food and Drug Administration, pursuant to
20 the following conditions:
21 (A) the vaccine must be authorized or licensed by
22 the United States Food and Drug Administration;
23 (B) the vaccine must be ordered and administered
24 according to the Advisory Committee on Immunization
25 Practices standard immunization schedule;
26 (C) the pharmacist must complete a course of
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1 training accredited by the Accreditation Council on
2 Pharmacy Education or a similar health authority or
3 professional body approved by the Division of
4 Professional Regulation;
5 (D) the pharmacist must have a current certificate
6 in basic cardiopulmonary resuscitation;
7 (E) the pharmacist must complete, during each
8 State licensing period, a minimum of 2 hours of
9 immunization-related continuing pharmacy education
10 approved by the Accreditation Council on Pharmacy
11 Education;
12 (F) the pharmacist must comply with recordkeeping
13 and reporting requirements of the jurisdiction in
14 which the pharmacist administers vaccines, including
15 informing the patient's primary-care provider, when
16 available, and complying with requirements whereby the
17 person administering a vaccine must review the vaccine
18 registry or other vaccination records prior to
19 administering the vaccine; and
20 (G) the pharmacist must inform the pharmacist's
21 patients who are less than 18 years old, as well as the
22 adult caregiver accompanying the child, of the
23 importance of a well-child visit with a pediatrician
24 or other licensed primary-care provider and must refer
25 patients as appropriate;
26 (16) the ordering and administration of COVID-19
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1 therapeutics subcutaneously, intramuscularly, or orally
2 with notification to the patient's physician and
3 appropriate record retention or pursuant to hospital
4 pharmacy and therapeutics committee policies and
5 procedures. Eligible therapeutics are those approved,
6 authorized, or licensed by the United States Food and Drug
7 Administration and must be administered subcutaneously,
8 intramuscularly, or orally in accordance with that
9 approval, authorization, or licensing; and
10 (17) the ordering and administration of tests and
11 screenings for (i) influenza, (ii) SARS-COV 2, and (iii)
12 health conditions identified by a statewide public health
13 emergency, as defined in the Illinois Emergency Management
14 Agency Act, with notification to the patient's physician
15 and appropriate record retention or pursuant to hospital
16 pharmacy and therapeutics committee policies and
17 procedures. Eligible tests and screenings are those
18 approved, authorized, or licensed by the United States
19 Food and Drug Administration and must be administered in
20 accordance with that approval, authorization, or
21 licensing.
22 A pharmacist who orders or administers tests or
23 screenings for health conditions described in this
24 paragraph may use a test that may guide clinical
25 decision-making for the health condition that is waived
26 under the federal Clinical Laboratory Improvement
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1 Amendments of 1988 and regulations promulgated thereunder
2 or any established screening procedure that is established
3 under a statewide protocol.
4 A pharmacist may delegate the administrative and
5 technical tasks of performing a test for the health
6 conditions described in this paragraph to a registered
7 pharmacy technician or student pharmacist acting under the
8 supervision of the pharmacist.
9 A pharmacist who performs any of the acts defined as the
10 practice of pharmacy in this State must be actively licensed
11 as a pharmacist under this Act.
12 (e) "Prescription" means and includes any written, oral,
13 facsimile, or electronically transmitted order for drugs or
14 medical devices, issued by a physician licensed to practice
15 medicine in all its branches, dentist, veterinarian, podiatric
16 physician, or optometrist, within the limits of his or her
17 license, by a physician assistant in accordance with
18 subsection (f) of Section 4, or by an advanced practice
19 registered nurse in accordance with subsection (g) of Section
20 4, containing the following: (1) name of the patient; (2) date
21 when prescription was issued; (3) name and strength of drug or
22 description of the medical device prescribed; and (4)
23 quantity; (5) directions for use; (6) prescriber's name,
24 address, and signature; and (7) DEA registration number where
25 required, for controlled substances. The prescription may, but
26 is not required to, list the illness, disease, or condition
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1 for which the drug or device is being prescribed. DEA
2 registration numbers shall not be required on inpatient drug
3 orders. A prescription for medication other than controlled
4 substances shall be valid for up to 15 months from the date
5 issued for the purpose of refills, unless the prescription
6 states otherwise.
7 (f) "Person" means and includes a natural person,
8 partnership, association, corporation, government entity, or
9 any other legal entity.
10 (g) "Department" means the Department of Financial and
11 Professional Regulation.
12 (h) "Board of Pharmacy" or "Board" means the State Board
13 of Pharmacy of the Department of Financial and Professional
14 Regulation.
15 (i) "Secretary" means the Secretary of Financial and
16 Professional Regulation.
17 (j) "Drug product selection" means the interchange for a
18 prescribed pharmaceutical product in accordance with Section
19 25 of this Act and Section 3.14 of the Illinois Food, Drug and
20 Cosmetic Act.
21 (k) "Inpatient drug order" means an order issued by an
22 authorized prescriber for a resident or patient of a facility
23 licensed under the Nursing Home Care Act, the ID/DD Community
24 Care Act, the MC/DD Act, the Specialized Mental Health
25 Rehabilitation Act of 2013, the Hospital Licensing Act, or the
26 University of Illinois Hospital Act, or a facility which is
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1 operated by the Department of Human Services (as successor to
2 the Department of Mental Health and Developmental
3 Disabilities) or the Department of Corrections.
4 (k-5) "Pharmacist" means an individual health care
5 professional and provider currently licensed by this State to
6 engage in the practice of pharmacy.
7 (l) "Pharmacist in charge" means the licensed pharmacist
8 whose name appears on a pharmacy license and who is
9 responsible for all aspects of the operation related to the
10 practice of pharmacy.
11 (m) "Dispense" or "dispensing" means the interpretation,
12 evaluation, and implementation of a prescription drug order,
13 including the preparation and delivery of a drug or device to a
14 patient or patient's agent in a suitable container
15 appropriately labeled for subsequent administration to or use
16 by a patient in accordance with applicable State and federal
17 laws and regulations. "Dispense" or "dispensing" does not mean
18 the physical delivery to a patient or a patient's
19 representative in a home or institution by a designee of a
20 pharmacist or by common carrier. "Dispense" or "dispensing"
21 also does not mean the physical delivery of a drug or medical
22 device to a patient or patient's representative by a
23 pharmacist's designee within a pharmacy or drugstore while the
24 pharmacist is on duty and the pharmacy is open.
25 (n) "Nonresident pharmacy" means a pharmacy that is
26 located in a state, commonwealth, or territory of the United
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1 States, other than Illinois, that delivers, dispenses, or
2 distributes, through the United States Postal Service,
3 commercially acceptable parcel delivery service, or other
4 common carrier, to Illinois residents, any substance which
5 requires a prescription.
6 (o) "Compounding" means the preparation and mixing of
7 components, excluding flavorings, (1) as the result of a
8 prescriber's prescription drug order or initiative based on
9 the prescriber-patient-pharmacist relationship in the course
10 of professional practice or (2) for the purpose of, or
11 incident to, research, teaching, or chemical analysis and not
12 for sale or dispensing. "Compounding" includes the preparation
13 of drugs or devices in anticipation of receiving prescription
14 drug orders based on routine, regularly observed dispensing
15 patterns. Commercially available products may be compounded
16 for dispensing to individual patients only if all of the
17 following conditions are met: (i) the commercial product is
18 not reasonably available from normal distribution channels in
19 a timely manner to meet the patient's needs and (ii) the
20 prescribing practitioner has requested that the drug be
21 compounded.
22 (p) (Blank).
23 (q) (Blank).
24 (r) "Patient counseling" means the communication between a
25 pharmacist or a student pharmacist under the supervision of a
26 pharmacist and a patient or the patient's representative about
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1 the patient's medication or device for the purpose of
2 optimizing proper use of prescription medications or devices.
3 "Patient counseling" may include without limitation (1)
4 obtaining a medication history; (2) acquiring a patient's
5 allergies and health conditions; (3) facilitation of the
6 patient's understanding of the intended use of the medication;
7 (4) proper directions for use; (5) significant potential
8 adverse events; (6) potential food-drug interactions; and (7)
9 the need to be compliant with the medication therapy. A
10 pharmacy technician may only participate in the following
11 aspects of patient counseling under the supervision of a
12 pharmacist: (1) obtaining medication history; (2) providing
13 the offer for counseling by a pharmacist or student
14 pharmacist; and (3) acquiring a patient's allergies and health
15 conditions.
16 (s) "Patient profiles" or "patient drug therapy record"
17 means the obtaining, recording, and maintenance of patient
18 prescription information, including prescriptions for
19 controlled substances, and personal information.
20 (t) (Blank).
21 (u) "Medical device" or "device" means an instrument,
22 apparatus, implement, machine, contrivance, implant, in vitro
23 reagent, or other similar or related article, including any
24 component part or accessory, required under federal law to
25 bear the label "Caution: Federal law requires dispensing by or
26 on the order of a physician". A seller of goods and services
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1 who, only for the purpose of retail sales, compounds, sells,
2 rents, or leases medical devices shall not, by reasons
3 thereof, be required to be a licensed pharmacy.
4 (v) "Unique identifier" means an electronic signature,
5 handwritten signature or initials, thumb print, or other
6 acceptable biometric or electronic identification process as
7 approved by the Department.
8 (w) "Current usual and customary retail price" means the
9 price that a pharmacy charges to a non-third-party payor.
10 (x) "Automated pharmacy system" means a mechanical system
11 located within the confines of the pharmacy or remote location
12 that performs operations or activities, other than compounding
13 or administration, relative to storage, packaging, dispensing,
14 or distribution of medication, and which collects, controls,
15 and maintains all transaction information.
16 (y) "Drug regimen review" means and includes the
17 evaluation of prescription drug orders and patient records for
18 (1) known allergies; (2) drug or potential therapy
19 contraindications; (3) reasonable dose, duration of use, and
20 route of administration, taking into consideration factors
21 such as age, gender, and contraindications; (4) reasonable
22 directions for use; (5) potential or actual adverse drug
23 reactions; (6) drug-drug interactions; (7) drug-food
24 interactions; (8) drug-disease contraindications; (9)
25 therapeutic duplication; (10) patient laboratory values when
26 authorized and available; (11) proper utilization (including
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1 over or under utilization) and optimum therapeutic outcomes;
2 and (12) abuse and misuse.
3 (z) "Electronically transmitted prescription" means a
4 prescription that is created, recorded, or stored by
5 electronic means; issued and validated with an electronic
6 signature; and transmitted by electronic means directly from
7 the prescriber to a pharmacy. An electronic prescription is
8 not an image of a physical prescription that is transferred by
9 electronic means from computer to computer, facsimile to
10 facsimile, or facsimile to computer.
11 (aa) "Medication therapy management services" means a
12 distinct service or group of services offered by licensed
13 pharmacists, physicians licensed to practice medicine in all
14 its branches, advanced practice registered nurses authorized
15 in a written agreement with a physician licensed to practice
16 medicine in all its branches, or physician assistants
17 authorized in guidelines by a supervising physician that
18 optimize therapeutic outcomes for individual patients through
19 improved medication use. In a retail or other non-hospital
20 pharmacy, medication therapy management services shall consist
21 of the evaluation of prescription drug orders and patient
22 medication records to resolve conflicts with the following:
23 (1) known allergies;
24 (2) drug or potential therapy contraindications;
25 (3) reasonable dose, duration of use, and route of
26 administration, taking into consideration factors such as
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1 age, gender, and contraindications;
2 (4) reasonable directions for use;
3 (5) potential or actual adverse drug reactions;
4 (6) drug-drug interactions;
5 (7) drug-food interactions;
6 (8) drug-disease contraindications;
7 (9) identification of therapeutic duplication;
8 (10) patient laboratory values when authorized and
9 available;
10 (11) proper utilization (including over or under
11 utilization) and optimum therapeutic outcomes; and
12 (12) drug abuse and misuse.
13 "Medication therapy management services" includes the
14 following:
15 (1) documenting the services delivered and
16 communicating the information provided to patients'
17 prescribers within an appropriate time frame, not to
18 exceed 48 hours;
19 (2) providing patient counseling designed to enhance a
20 patient's understanding and the appropriate use of his or
21 her medications; and
22 (3) providing information, support services, and
23 resources designed to enhance a patient's adherence with
24 his or her prescribed therapeutic regimens.
25 "Medication therapy management services" may also include
26 patient care functions authorized by a physician licensed to
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1 practice medicine in all its branches for his or her
2 identified patient or groups of patients under specified
3 conditions or limitations in a standing order from the
4 physician.
5 "Medication therapy management services" in a licensed
6 hospital may also include the following:
7 (1) reviewing assessments of the patient's health
8 status; and
9 (2) following protocols of a hospital pharmacy and
10 therapeutics committee with respect to the fulfillment of
11 medication orders.
12 (bb) "Pharmacist care" means the provision by a pharmacist
13 of medication therapy management services, with or without the
14 dispensing of drugs or devices, intended to achieve outcomes
15 that improve patient health, quality of life, and comfort and
16 enhance patient safety.
17 (cc) "Protected health information" means individually
18 identifiable health information that, except as otherwise
19 provided, is:
20 (1) transmitted by electronic media;
21 (2) maintained in any medium set forth in the
22 definition of "electronic media" in the federal Health
23 Insurance Portability and Accountability Act; or
24 (3) transmitted or maintained in any other form or
25 medium.
26 "Protected health information" does not include
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