216-RICR-10-10-6
216-RICR-10-10-6. Regional Health Information Organization and Health Information Exchange (version Amendment, 08/27/2018 to 01/04/2022)
6.1 Authority
These regulations are
promulgated pursuant to the authority conferred under R.I. Gen. Laws
§ 5-37.7-5 for the purpose of establishing safeguards and
confidentiality protections for the Health Information Exchange (HIE)
in order to improve the quality, safety and value of health care,
keep confidential health information secure and confidential and use
the HIE to progress toward meeting public health goals.
6.2 Definitions
A. Wherever used in this Part,
the following terms shall be construed as follows:
1. “Act” means R.I. Gen.
Laws Chapter 5-37.7 entitled, “The Rhode Island Health Information
Exchange Act of 2008.”
2. “Administrative review”
means the administrative processes contained in rules and regulations
pertaining to Practices and Procedures Before the Rhode Island
Department of Health (Subchapter 05 Part 4 of this Chapter), and as
otherwise permitted by the Administrative Procedures Act.
3. "Authorized
representative" means:
a. A person empowered by the
patient participant to assert or to waive confidentiality, or to
disclose or authorize the disclosure of confidential information, as
established by this Part. That person is not, except by explicit
authorization, empowered to waive confidentiality or to disclose or
consent to the disclosure of confidential information; or
b. A person appointed by the
patient participant to make health care decisions on his or her
behalf through a valid durable power of attorney for health care as
set forth in R.I. Gen. Laws § 23-4.10-2; or
c. A guardian or conservator,
with authority to make health care decisions, if the patient
participant is decisionally impaired; or
d. Another legally appropriate
medical decision maker, temporarily, if the patient participant is
decisionally impaired and no health care agent, guardian or
conservator is available; e. If the patient participant is deceased,
his or her personal representative or, in the absence of that
representative, his or her heirs-at-law;
e. A parent with the authority
to make health care decisions for the parent's child; or
f. A person authorized by the
patient participant or their authorized representative to access
their confidential health information from the HIE, including family
members or other proxies as designated by the patient, to assist
patient participant with the coordination of their care.
4. "Authorization form"
means the form described in § 6.5.4 of this Part and by which a
patient participant provides authorization for the RHIO to allow
access to, review of, and/or disclosure of the patient participant's
confidential health information by electronic, written or other
means.
5. "Business associate"
means a business associate as defined by HIPAA, and its implementing
regulations (45 C.F.R. §§ 160 through 164).
6. "Confidential health
information" means all identifiable information relating to a
patient participant's health care history, diagnosis, condition,
treatment, or evaluation.
7. "Data submitting
partner" means an individual, organization or entity that has
entered into a business associate agreement with the RHIO and submits
patient participants' confidential health information through the
HIE.
8. "Department"
means the Rhode Island Department of Health.
9. “Director” means the
Director of the Rhode Island Department of Health or his/her
designee(s).
10. "Disclosure report"
means a report generated by the HIE relating to the record of access
to, review of and/or disclosure of a patient's confidential health
information received, accessed or held by the HIE.
11. "Electronic
mobilization" means the capability to move clinical information
electronically between disparate health information systems while
maintaining the accuracy of the information being exchanged.
12. "Health care
provider" means any person or entity licensed by this state to
provide or lawfully providing health care services, including, but
not limited to, a physician, hospital, intermediate care facility or
other health care facility, dentist, nurse, optometrist, podiatrist,
physical therapist, psychiatric social worker, pharmacist or
psychologist, and any officer, employee, or agent of that provider
acting in the course and scope of his or her employment or agency
related to or supportive of health care services.
13. "Health care
services" means acts of diagnosis, treatment, medical
evaluation, referral or counseling or any other acts that may be
permissible under the health care licensing statutes of this state.
14. "Health Information
Exchange" or "HIE" means the technical system operated
by the RHIO under state authority allowing for the statewide
electronic mobilization of confidential health information, pursuant
to the Act and this Part.
15. "Health plan"
means an individual plan or a group plan that provides, or pays the
cost of, health care services for patient participants.
16. "HIE Advisory
Commission" means the advisory body established by the
Department in order to provide community input and policy
recommendations regarding the use of the confidential health
information of the HIE.
17. "HIPAA" means
the Health Insurance Portability and Accountability Act of 1996, as
amended, and its implementing regulations (45 C.F.R. §§ 160 through
164).
18. “HIPAA Final Omnibus
Rule” means the HIPAA regulations promulgated and effective March
25, 2013.
19. “HITECH” means the
Health Information Technology for Economic and Clinical Health Act of
2009, Public Law 111-5 and its implementing regulations.
20. "Participant"
means a patient participant, a patient participant's authorized
representative, a provider participant, a data submitting partner,
the regional health information organization and the Department, that
has agreed to authorize, submit, access and/or disclose confidential
health information via the HIE in accordance with the Act and this
Part.
21. "Participation"
means a participant's authorization, submission, access and/or
disclosure of confidential health information in accordance with the
Act and this Part.
22. "Patient participant"
means a person who receives health care services from a provider
participant and has agreed to participate in the HIE through the
mechanisms established in the Act and this Part.
23. “Protected health
information” means individually identifiable health information
including demographic information that is collected from an
individual and is created or received by a health care provider,
health plan, employer or health care clearinghouse that relates to
the past, present, or future physical or mental health or condition
of an individual; the provision of health care to an individual; or
the past, present, or future payment for the provision of health care
to an individual that identifies the individual or with respect to
which there is a reasonable basis to believe the information can be
used to identify the individual.
24. "Provider
participant" means a pharmacy, laboratory, health care provider,
or health plan that is providing health care services or pays for
the cost of health care services for a patient participant and/or is
submitting or accessing health information through the HIE and has
executed an electronic and/or written agreement regarding disclosure,
access, receipt, retention or release of confidential health
information to the HIE.
25. "Regional health
information organization" or "RHIO" means the
organization designated as the RHIO by the State of Rhode Island to
provide administrative and operational support to the HIE.
26. “Unanticipated events”
means instances in which the provider participant is unavailable and
another health care provider is providing coverage to treat the
patient participant.
27. “Unsecured protected
health information” means protected health information that is not
rendered unusable, unreadable, or indecipherable to unauthorized
persons through the use of a technology or methodology specified by
the United States Secretary of Health and Human Services in guidance
issued under section 13402(h)(2) of Public Law 111-5.
6.3 General Provisions
6.3.1 Participation in the
Health Information Exchange (HIE)
A. A statewide Health
Information Exchange (HIE) has been established pursuant to R.I. Gen.
Laws Chapter 5-37.7. Confidential health information shall only be
accessed, released or transferred from the HIE pursuant to R.I. Gen.
Laws Chapter 5-37.7. In addition to the requirements set forth in
R.I. Gen. Laws 5-37.7:
1. Participation in the HIE is
voluntary; and may be terminated at any time. Patients and health
care providers shall have the choice to participate in the HIE, as
defined by the Act and this Part. Patient participants shall agree to
participate by signing an authorization form provided by the HIE.
Patient participants may terminate their participation in the RI HIE
pursuant to § 6.5.1(A)(6) of this Part.
2. Individuals shall be
informed about the opportunity to enroll in the HIE through provider
participants and other publicly available means. Individuals will be
informed about the HIE through materials that explain the context and
process of HIE enrollment, including any and all choices available to
the individual such as identifying which provider participants will
be able to view their health care information through the HIE.
3. Individuals will be
informed that by enrolling in the HIE, at a minimum, they are
authorizing health care providers that care for them in emergencies
or other unscheduled events, to access their health information
through the RI HIE on a temporary basis. Individuals will also be
informed that in addition to the ability to terminate enrollment in
the HIE, they have the ability to revoke authorization of a provider
participant to further access their health information through the
HIE consistent with § 6.5.1 of this Part.
4. The RHIO shall maintain a
dedicated telephone number staffed with qualified personnel who can
respond to individuals’ questions related to enrollment choices and
processes. If there are remaining concerns or complaints after
contacting the RHIO, individuals can contact the Department of Health
“Health Information Line.”
5. The RHIO shall maintain a
process for reviewing and resolving complaints related to it, and to
assist patient participants in resolving complaints.
a. The RHIO and all provider
participants will accept complaints pertaining to the RI HIE.
Provider participants will forward complaints to the RHIO.
b. The RHIO will appoint a
Privacy Officer who will review all complaints. Complaints will not
be public and will be kept confidential as permitted by law. Any
confidential health information contained in the complaint will be
protected in accordance with applicable state and federal law.
c. Neither the RHIO nor
provider participants will retaliate, discriminate against,
intimidate, coerce or otherwise reprise patient participants or
patient advocates relating to the filing of a complaint or for filing
a complaint.
d. The RHIO will contractually
require provider participants to comply with HIPAA, including
establishing and implementing HIPAA compliant policies and
procedures.
e. Patient participants may
lodge a complaint with the provider participant directly, with the
RHIO or with the Department of Health. If a complaint is lodged
directly with the RHIO and the RHIO refers the patient participant to
the provider participant and the provider participant cannot directly
resolve the complaint or believes the complaint is in error, the
patient participant may then submit it to the RHIO Privacy Officer
for review and assistance as requested by the patient participant.
f. All patient participants
lodging complaints directly with the RHIO will be directed to fill
out a patient complaint form and will be given assistance if
requested. If the complaint involves a provider participant, the RHIO
will notify the provider participant if it addresses actions by the
provider participant.
g. Any complaint regarding
breach of security, if appropriate, may invoke the response to breach
procedures by the RHIO.
h. The RHIO shall maintain
copies of all written patient complaint forms.
i. The disposition of the
complaint shall be documented by the RHIO Privacy Officer as part of
the complaint process.
j. For complaints lodged
directly to the Department, the Department will follow its usual
process for investigating complaints and the complaint shall remain
confidential to the public until it has been resolved. If applicable,
once it is resolved, the Department will notify the RHIO Privacy
Officer and/or provider participant. Any patient participant wishing
to lodge a verbal complaint may do so by calling the Department of
Health “Health Information Line.”
k. Any complaint lodged by a
patient participant with the provider participant, the RHIO or the
Department shall be resolved within thirty (30) days of submission.
l. The Department reserves the
right to access the records of complaints received by the RHIO and
the resolution of such complaints.
6.3.2 Rhode Island Regional
Health Information Organization (RHIO)
A. The RHIO shall function
pursuant to R.I. Gen. Laws Chapter 5-37.7. Additionally, the RHIO
shall develop and implement current policies and procedures
including, but not limited to, the following topics:
1. Participant enrollment
(health care provider, health plan, and individual) that is
consistent with § 6.3.1(A)(1) of this Part;
2. Patient participant’s
termination of enrollment that is consistent with §§ 6.3.1(A)(1)
and 6.5 of this Part;
3. Termination of patient
participant authorization for provider participant access that is
consistent with § 6.5.1(A)(5) of this Part;
4. Handling patient
participant complaints and inquiries that is consistent with §
6.3.1(A)(2) of this Part;
5. The process through which a
patient participant can obtain a copy of his or her confidential
health information from the HIE that is consistent with §
6.5.1(A)(1) of this Part;
6. The process through which a
patient participant can obtain a copy of the disclosure report
pertaining to his or her confidential health information consistent
with § 6.5.1(A)(4) of this Part;
7. Patient participant
requests to amend his or her own information through the provider
participant consistent with § 6.3.3(A)(2) of this Part;
8. Tiered access to
confidential health information (i.e., criteria and controls to
obtain varying degrees of access to data maintained by the HIE)
consistent with § 6.3.3 of this Part;
9. Privacy, confidentiality
and security pertaining to access and maintenance of patient
participant confidential health information consistent with §§ 6.5
and 6.6 of this Part;
10. Temporary access to HIE
data by provider participants that need to treat a person in
emergencies or other unanticipated events consistent with §
6.3.1(A)(1) of this Part; and
11. Patient participant
notification, if required by either R.I. Gen. Laws Chapter 11-49.3
[Rhode Island Identity Theft Protection Act of 2015] or the HIPAA
Final Omnibus Rule, regarding a detected breach of the security of
the system of the HIE that may have resulted in the unauthorized
access, use or disclosure of protected health information, personal
information or Unsecured Protected Health Information consistent with
§ 6.5.1(A)(5) of this Part.
B. The RHIO shall utilize a
committee structure that encourages community involvement and
transparency in the process of the development and implementation of
its policies.
C. Patient participants have
the right to access the RHIO’s notice of privacy practices which
will be posted on the RHIO’s websites, www.riqi.org and
www.currentcareri.org. The Notice of Privacy Practices will be
written in plain language and will contain applicable information
such as: the uses and disclosures of PHI through the HIE, patient
participants’ individual rights, the RHIO’s responsibilities
regarding the privacy of patient participants’ information and the
complaint process.
D. In the event that the RHIO
fails to comply with this Part or has policies that do not comply
with federal and state laws, rules and regulations, the Director may
notify the RHIO by certified or registered mail or by personal
service setting forth the failure(s) and the RHIO shall be given the
opportunity to cure such failure within the time designated by the
Director. If the RHIO does not cure the failure, the Department may
invoke contractual remedies, require specific monitoring or
supervision to occur, or limit or suspend actions of the RHIO until
such time as the corrective action has cured the failure. The
Department may also notify the Secretary of the United State
Department of Health and Human Services and the Rhode Island
Department of Attorney General if the Department of Health believes
the failure to comply with this Part amounts to a HIPAA violation.
The RHIO, or the Department may request a prompt and fair hearing in
accordance with R.I. Gen. Laws § 42-35-9. Nothing in this Part shall
limit the authority of the jurisdiction conferred upon the Department
of Attorney General to bring an action against the RHIO pursuant to §
6.8 of this Part for a violation of this Part and/or HITECH.
E. In the event of the
insolvency or involuntary dissolution of the RHIO, the assets and
operations comprising the HIE, including the protection of the
protected health information of the enrollees of the HIE, shall be
transitioned or transferred in accordance with an Order of a court of
proper jurisdiction.
F. In the event of a voluntary
dissolution of the RHIO, the RHIO will give the Department thirty
(30) days’ notice. The Department has a contractual right of first
refusal to purchase only the assets comprising the HIE at the
appraised value.
G. In the event of either of
the above, the RHIO shall be responsible to safeguard the protected
health information in its care, custody and control until the PHI has
been transferred to another entity.
6.3.3 Special Requirements
Pertaining to the Health Information Exchange (HIE) and the Rhode
Island Regional Health Information Organization (RHIO)
A. Pursuant to R.I. Gen. Laws
§ 5-37.7-4(e), the HIE and the RHIO have an obligation to maintain,
and abide by the terms of, HIPAA-compliant business associate
agreements, as well as:
1. The RHIO will maintain user
access permission profiles to determine which PHI may be accessed by
authorized users according to specific role classification and shall
implement policies and procedures regarding user authentication;
2. In response to a request by
a patient participant to make an amendment to his/her PHI contained
in the HIE, the RHIO will provide the patient participant with a
“Request to Amend Health Information” form to submit to the
originating provider participant and if so directed by the provider
participant, will amend the record in accordance with HIPAA, the Act
and this Part. The “Request to Amend Health Information” form
shall be available from the CurrentCare website
(www.currentcareri.org), by calling the RHIO, or by requesting the
form in writing.
a. As soon as possible, but no
later than sixty (60) days after receipt of a request from a patient
participant to amend health information, the provider participant
shall either forward the corrected information to the RHIO for
processing or notify the patient participant, in writing, why the
request to amend health information has been denied.
b. As soon as possible, but no
later than thirty (30) days after receipt of a request from a
provider participant to amend a confidential health care record, the
RHIO/HIE shall process the request and notify the provider
participant, in writing, that the requested amendment to health
information has been completed.
3. If the patient participant
requests a change to his or her CurrentCare record, and the RHIO
determines that the change is due to an operational issue, the RHIO
will address the error pursuant to its internal error resolution
procedures by making the correction and notifying the patient
participant within thirty (30) days of the correction that the
correction has been made.
4. The RHIO shall have written
data sharing agreements in place with provider participants who
submit data to the HIE. Such agreements shall, at a minimum, contain
all required business associate agreement components.
5. The RHIO shall have written
end user agreements in place with provider participants who access
data in the HIE. Such agreements shall, at a minimum, describe roles
and responsibilities of both the end user and the RHIO regarding
appropriate use of the HIE and assuring patient rights in accordance
with applicable federal and state law.
6.3.4 Reconciliation with
Other Authorities
Reconciliation with other
authorities shall be pursuant to R.I. Gen. Laws § 5-37.7-12.
6.3.5 Professional
Responsibilities
In accordance with applicable
state laws and regulations promulgated thereunder, a provider
participant that abandons a patient or denies treatment to a new or
existing patient solely on the basis of the patient’s refusal to
participate in the HIE, when the patient’s health information can
be obtained from other sources, may be subject to administrative
review by the Department, including, but not limited to the
Department’s Professional Boards, and the Director. The processes
contained in rules and regulations pertaining to Practices and
Procedures Before the Rhode Island Department of Health (Subchapter
05 Part 4 of this Chapter), and as otherwise permitted by the
Administrative Procedures Act, shall apply.
6.4 HIE Advisory Commission
A. Pursuant to R.I. Gen. Laws
§ 5-37.7-5(c), the Director shall establish an HIE Advisory
Commission of no more than nine (9) members that shall be responsible
for recommendations relating to the type of and use of, and
appropriate confidentiality protection for, the confidential health
information of the HIE, subject to regulatory oversight by the
Department. The responsibilities of the HIE Advisory Commission shall
be pursuant to R.I. Gen. Laws § 5-37.7-5.
B. Pursuant to R.I. Gen. Laws
§ 5-37.7-5(c), the Director shall recommend prospective HIE Advisory
Commission members to the Governor, subject to the advice and consent
of the Senate. The membership of the HIE Advisory Commission shall
include one (1) person with experience in HIPAA and privacy and
security of health care information requirements, one (1) person with
experience in operations, maintenance and security of complex
electronic databases, one (1) person who is a health care consumer or
consumer advocate, one (1) person who represents a minority or
underserved population, one (1) person who has experience in
epidemiology and the use of data for public health purposes, and no
more than three (3) persons employed by a health care delivery
organization, at least two (2) of whom shall be a physician licensed
pursuant to R.I. Gen. Laws Chapter 5-37. The remaining member(s)
shall be selected from business professionals and health care
consumers whose experience and expertise will facilitate the work of
the Commission.
C. The Director shall appoint
a chairperson for the HIE Advisory Commission.
D. HIE Advisory Commission
members shall be appointed for a term of two (2) years. A Commission
member may be reappointed for an additional term, but shall not be
eligible to serve more than three (3) consecutive terms. RHIO staff
and board members shall not be eligible for appointment to the
Commission.
E. The HIE Advisory Commission
shall meet at least annually and shall not vote on any
recommendations regarding the use of confidential health information
unless a quorum is present.
F. The HIE Advisory Commission
shall report annually to the Department and the RHIO, and such report
shall be made public.
G. The HIE Advisory Commission
shall actively obtain and consider public input on all
recommendations prior to submitting them to the Director. All
meetings of the HIE Advisory Commission shall be subject to R.I. Gen.
Laws Chapter 42-46 (Open Meetings).
H. The Director may recommend
to the Governor that any HIE Advisory Commission member be removed
for cause, including but not limited to, failure to attend Commission
meetings on a regular basis.
6.5 Confidentiality Protections
6.5.1 Patients’ Rights
A. In addition to the
requirements of R.I. Gen. Laws Chapter 5-37.7 and this Part, a
patient participant who has his or her confidential health
information in the HIE shall have the following rights:
1. To obtain a copy of his/her
confidential health information from the HIE by:
a. Submitting a valid and
authenticated request to access the HIE record via the methods made
available by the RHIO.
b. The form and methods shall
be publicly available through posting on the HIE website
(www.currentcareri.org) including enrolling in CurrentCare for Me.
c. Requestors may also call
the CurrentCare information line to complete and submit the
information on the form over the phone. To do so, the requestor must
successfully complete the requirements of the identity verification
process by supplying identifying information through a series of
questions initiated by a RHIO representative over the phone and for
the sole purpose of a single occurrence of a telephone request to
submit the form.
d. If the requestor prefers,
he or she may fill out a form in person at the RHIO offices after
identity verification has occurred. The requestor may either obtain
an enrollee request to access record form via the website or request
a form be mailed to them.
e. If neither is possible,
then the requestor may send a letter containing the same information
as is required by the form and have it authenticated in the same
manner as the written form.
2. To designate which provider
participant(s) are authorized to access his/her confidential health
information through the HIE by completing a valid and authenticated
enrollment and authorization form setting forth the provider
participants who are authorized to have access to his/her
confidential health information through the HIE. The form shall be
publicly available through posting on the HIE website
( www.currentcareri.org );
or the patient participant or their authorized representative may
request in writing or over the telephone that a form be sent to them.
3. A patient participant at
any time after enrollment may change his or her authorization for a
provider participant to access his/her information through the RI HIE
by completing a valid and authenticated form requesting an amendment
or termination of authorization. The form, along with information
about where to submit the form, shall be publicly available through
posting on the HIE website ( www.currentcareri.org ).
4. To obtain a copy of the
disclosure report pertaining to his or her confidential health
information by submitting a request for a disclosure report. The
forms along with information about where to submit the form shall be
publicly available through posting on the HIE website
( www.currentcareri.org );
The RHIO will make every effort to provide disclosure reports in a
prompt manner while recognizing that state and federal law allow up
to sixty (60) days to respond. If extenuating circumstances arise,
the RHIO may have an additional thirty (30) days to provide the
disclosure report to the enrollee. Each request for disclosure
history will be addressed in accordance with 45 C.F.R. § 164.528(a).
A charge for a copy of the disclosure report may be imposed if
consistent with state law.
5. To be notified, if required
by either R.I. Gen. Laws Chapter 11-49.2 [Rhode Island Identity Theft
Protection Act], or the HIPAA Final Omnibus Rule, of a breach of the
security system of the HIE that resulted in the unauthorized access,
use or disclosure of personal information or unsecured protected
health information.
6. To terminate his or her
participation in the HIE at any time in accordance with the Act and
this Part by submitting a Revocation of Authorization form to the
RHIO. The form and methods for termination shall be publicly
available through posting on the HIE website ( www.currentcareri.org )
or the patient participant or authorized representative may call the
RHIO to request a form be sent to them.
7. To revoke access of
provider participants to the patient participant’s health
information at any time in accordance with the Act and this Part by
submitting a Revocation of Authorization Form. The form and methods
for revocation of access of provider participant to the patient
participant’s health information shall be publicly available
through posting on the HIE website (www.currentcareri.org) or the
patient participant or authorized representative may call the RHIO to
request a form be sent to them.
8. Upon a patient
participant’s completed termination of enrollment from the HIE, no
additional confidential health information for that patient will be
collected by the HIE and the patient’s confidential health
information in the HIE will no longer be accessible to a provider
participant. Nothing in this Part shall preclude a provider
participant from accessing the provider participant’s own record of
the patient. The revocation of a patient’s authorization will not
affect the previous disclosures or access to the patient’s health
information while the patient’s authorization and enrollment was in
effect.
9. Since the HIE does not
create patient confidential health information, but receives
confidential health information from provider participants, the
patient participant may request to amend his or her own information
through provider participants by submitting a request to amend
confidential health information form consistent with this Part. The
form and methods shall be publicly available through posting on the
HIE website ( www.currentcareri.org )
or the patient participant or authorized representative may call the
RHIO to request a form be sent to them. The RHIO will respond
directly to a patient participant request and follow its policies and
procedures if there is an administrative error that does not require
an amendment to the record received from the provider participant.
6.5.2 Confidentiality
Protections
Confidentiality protections
for patient participants in the HIE are pursuant to R.I. Gen. Laws
Chapter 5-37.7 and this Part; additionally the Department reserves
the right to review the policies and procedures applicable to the HIE
bi-annually to help assess successes and areas for improvement.
6.5.3 Secondary Disclosure
Secondary disclosure rules
shall be pursuant to those stated in R.I. Gen. Laws § 5-37.7-9.
6.5.4 Authorization Form
A. The authorization form for
enrollment into the HIE, access to, or the disclosure, release or
transfer of, confidential health information from the HIE shall
conform with the requirements of R.I. Gen. Laws Chapter 5-37.7; and
additionally contain other information required by the RHIO, in
consultation with the Director.
B. Except as specifically set
forth in R.I. Gen. Laws § 5-37.7-7(b), the RHIO shall not allow
access to or disclosure of a patient participant’s confidential
health information unless it is in accordance with the patient
participant’s authorization on the enrollment form.
C. Except as set forth in R.I.
Gen. Laws § 5-37.7-7(b), the RHIO will not allow access to or
disclosure of a patient participant’s confidential health
information to a provider participant unless the recipient has
entered into a Data Use Agreement with the RHIO.
D. The RHIO shall not accept
or respond to any authorization for requesting disclosure of the
patient participant’s health information for any purpose other than
as set forth by the Act and this Part.
E. Any request to enroll in
the HIE or to withdraw or terminate enrollment from the HIE pursuant
to § 6.5.1 of this Part shall be on forms which are provided by the
RHIO in accordance with § 6.5.1 of this Part. Requests to withdraw
or terminate enrollment from the HIE shall be made in accordance with
§ 6.5.1(A)(6) of this Part.
6.5.5 Release of
Confidential Health Information in Conjunction with Legal Proceedings
Release of confidential
health information in conjunction with legal proceedings shall occur
pursuant to R.I. Gen. Laws Chapter 5-37.7.
6.6 Security Requirements
6.6.1 Minimum Security
Requirements
The RHIO and HIE shall
implement security procedures pursuant to R.I. Gen. Laws § 5-37.7-8.
6.6.2 Safeguards and
Security Measures
The RHIO shall have in place
appropriate physical, technical and procedural safeguards and
security measures to ensure the technical integrity, physical safety,
and confidentiality of any confidential health information in the
HIE. These safeguards and security measures shall be in place at all
times and at any location at which the RHIO, its workforce members,
or its contractors hold or access confidential health information.
Such safeguards and security measures shall comply with state and
federal confidentiality laws and regulations including, without
limitation, the Health Insurance Portability and Accountability Act
of 1996 and its implementing regulations (45 C.F.R. §§ 160 through
164), HITECH and the HIPAA Final Omnibus Rule.
6.6.3 Security Framework
The RHIO shall develop
appropriate and scalable security standards, policies, and procedures
that are suitable for the size and complexity of its organization.
6.6.4 Security Management
A. The RHIO shall:
1. Maintain and effectively
implement written policies and procedures that conform to the
requirements of this Section to protect the confidentiality,
integrity, and availability of the confidential health information
that is processed, stored, and transmitted; to protect against any
reasonably anticipated threats or hazards to the security or
integrity of the confidential health information and to monitor,
modify and improve the effectiveness of such policies and procedures,
and
2. Train the RHIO workforce
who access or hold confidential health information regarding the
requirements of the Act, this Part and the RHIO's policies and
procedures regarding the confidentiality and security of confidential
health information. The RHIO will secure written acknowledgement of
training of its employees.
6.6.5 Separation of Systems
A. The RHIO shall:
1. Maintain confidential
health information, whether in electronic or other media, physically
and functionally separate from any other system of records;
2. Protect the media, whether
in electronic, paper, or other format, that contain confidential
health information, limiting access to authorized users and
sanitizing and destroying such media before disposal or release for
reuse; and
3. Establish physical and
environmental protections, to control and limit physical and virtual
access to places and equipment where confidential health information
is stored or used.
6.6.6 Security Control and
Monitoring
A. The RHIO shall:
1. Identify those authorized
to have access to confidential health information and an audit
capacity to detect unlawful, unauthorized or inappropriate access to
confidential health information, and
2. Establish measures to
prevent unauthorized removal, transmission or disclosure of
confidential health information in the HIE.
6.6.7 Security Assessment
A. The RHIO shall address:
1. Periodic assessments of
security risks and controls, as determined appropriate by the RHIO,
to establish if its controls are effective, to correct any deficiency
identified, and to reduce or eliminate any vulnerabilities.
2. System and communications
protection, to monitor, control, and protect RHIO uses,
communications, and transmissions involving confidential health
information to and from entities authorized to access the HIE.
6.7 Immunity and Waivers
Immunity and waiver rules
shall be pursuant to those stated in R.I. Gen. Laws §§ 5-37.7-11
and 5-37.7-14.
6.8 Penalties—Attorneys’ Fees
for Violations
Penalties shall be pursuant
to those stated in R.I. Gen. Laws § 5-37.7-13.