Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.11 - Biological Agents Registry Program
Section 10.10.11.23 - Trusted Partner Agreement
Universal Citation: MD Code Reg 10.10.11.23
Current through Register Vol. 51, No. 19, September 20, 2024
A. Requirement. The Department may not share BAR information with a person until the person becomes a trusted partner by entering into a trusted partner agreement, using the form developed by the Department.
B. The Department shall develop and use a trusted partner form that contains, as applicable, separate clauses that:
(1) Establish the length of time that the
trusted partner agreement is in effect;
(2) Address that confidentiality will survive
the termination, expiration, or cancellation of the trusted partner agreement
and state that the trusted partner:
(a) May
not use BAR information in a way that is detrimental to the
Department;
(b) Shall keep BAR
information confidential;
(c) Shall
limit disclosure of BAR information only:
(i)
To individuals with a legitimate need in performance of the individuals'
duties; and
(ii) On a need-to-know
basis as prescribed by this chapter; and
(d) Shall employ security policies that:
(i) Protect the confidentiality of BAR
information; and
(ii) Prevent
improper disclosures or access to BAR information;
(3) Require the trusted partner to
notify the Department whenever the trusted partner discloses BAR information as
allowed by this chapter;
(4)
Warrant and represent that the trusted partner is in compliance with all
applicable State and federal laws and regulations regarding BAR
information;
(5) Require the
trusted partner to execute a trusted partner agreement that upholds the
standards and requirements in the trusted partner agreement that the trusted
partner has with the Department;
(6) Require the trusted partner to notify the
Department when there is:
(a) An improper or
unauthorized:
(i) Disclosure of BAR
information; or
(ii) Access to BAR
information;
(b) A
misuse of BAR information;
(c) A
computer information system compromise that affects BAR information;
or
(d) An authorized release of BAR
information as set forth in this chapter;
(7) Address corrective action by stating:
(a) The steps necessary to prevent any
further unauthorized disclosure and misuse of BAR information;
(b) That the trusted partner shall maintain
an incident log of all unauthorized disclosures and misuse of BAR information;
and
(c) That the trusted partner
shall send a copy of incident log entries to the BAR Program;
(8) Require the trusted partner
to:
(a) Return the BAR information that was
provided to the trusted partner; and
(b) Exercise due diligence to destroy all
material based on BAR information in a manner that renders nonidentifiable all
documents, memoranda, notes, or other writings created or prepared by or for
the trusted partner or BAR information custodian;
(9) Require the trusted partner to make
available on demand to the Department all policies and procedures relevant to
safeguarding BAR information;
(10)
Address the authority of the individuals signing the trusted partner agreement
that state that:
(a) The individuals signing
the trusted partner agreement have the right and authority to execute the
agreement on behalf of their respective entity; and
(b) No further approvals are necessary to
make the trusted partner agreement binding;
(11) State that the trusted partner agreement
is the entire agreement between the Department and the trusted
partner;
(12) State that the
trusted partner agreement may not be amended, except as agreed to by the
Department in writing;
(13) State
that no provision or clause in the trusted partner agreement may be waived
unless approved in writing by the Department;
(14) Identify the individual designated by
the trusted partner and authorized by the Department to receive, maintain, and
if provided by this chapter, release BAR information;
(15) Attest that the BAR information
custodian has the trusted partner's agency clearance to receive BAR
information;
(16) Address a trusted
partner's security policy that states the:
(a)
Value of BAR information;
(b)
Protection responsibilities; and
(c) Organizational commitment for a system to
protect the integrity, confidentiality, and availability of BAR information;
and
(17) State that if a
provision, section, subsection, sentence, clause, or phrase of the trusted
partner agreement is held invalid, the remaining portions of the trusted
partner agreement remain valid.
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