Treadstone 71 HIPAA Certification and Accreditation
As part of HIPAA requirements, the Centers for Medicare and Medicaid
Services are working to establish a standard process, general tasks and
specific subtasks to certify and accredit IT systems supporting the healthcare
IT infrastructures. HIPAA will provide a new approach to certification and
accreditation (C&A) that uses the standardized process to verify the
correctness and effectiveness of security controls employed in a healthcare IT
system to ensure adequate security surrounding protect healthcare information
(PHI) is maintained. Treadstone 71 has been monitoring the progress of this
effort very closely. It is our informed belief that CMS will in fact employ
government standards for certification and accreditation (C&A) already in
place and in use by both DoD and non-DoD agencies. Treadstone 71 already
utilizes these proven and accepted practices (NIACAP Services) and is ready to
deploy them as part of our HIPAA Readiness Program. Treadstone 71’s use of
standardized, minimum security controls for low, moderate, and high levels of
concern for confidentiality, integrity, and availability and the employment of
standardized verification techniques and verification procedures promote:
- More consistent, comparable, and repeatable certifications
of IT systems;
- More complete, reliable information for HIPAA Security
Officers (HSO)—leading to a better understanding of complex IT systems and
associated risks and vulnerabilities; and
- More informed decisions by management officials supporting
the accreditation process.
While the certification and accreditation (C&A) process
focuses on healthcare IT systems processing, storing, and transmitting PHI, the
associated tasks and subtasks, security controls, and verification techniques
and procedures, have been broadly defined so as to be universally applicable to
all types of IT systems.
Healthcare management
responsibilities presume that responsible HSOs understand the risks and other
factors that could adversely affect the securing of PHI. Moreover, these HSOs
must understand the current status of security programs and controls in order
to make informed judgments and investments that appropriately mitigate risk to
an acceptable level.
The goal of the HSO is both to operate
their program and to do so with what is defined as adequate security, or
security commensurate with the risk and magnitude of harm resulting from the
loss, misuse, or unauthorized access to or modification of PHI. The
authorization of an IT system to process, store, or transmit PHI, granted by the
HSO provides a form of quality control and challenges managers and technical
staff to find the best fit for security, given technical constraints, operational
constraints, and mission requirements. Treadstone 71 refers to this
authorization as accreditation. Accreditation, which is required under
HIPAA, should be based on an assessment of the management, operational, and
technical controls associated with an IT system. Since the security plan
prepared by Treadstone 71 for healthcare organizations documents the protection
requirements and security controls for an IT system, the plan is the
fundamental document required in the accreditation process, (thereby reducing
unnecessary administrative duplication of effort), supplemented by more
specific studies as needed. In addition to the security plan, accreditation is
also supported by a risk assessment and security evaluation.
The Treadstone 71 risk
assessment identifies threats and vulnerabilities, analyzes security controls
planned or in place, determines likelihood that specific vulnerabilities may be
exploited, and provides an impact analysis. An initial risk assessment should
be initiated on the healthcare IT system prior to beginning the accreditation
process. The results of the initial risk assessment activities are used during
the security evaluation and revisited and possibly revised based on the
findings of the evaluation. Treadstone 71’s comprehensive evaluation of the
technical and non-technical security controls of a healthcare IT system to
support the accreditation process that establishes the extent to which a
particular design and implementation meets a set of specified security
requirements, is called certification.
Certification provides the necessary
information to the HSO to formally declare that a healthcare IT system is
approved to operate at an acceptable level of risk. The decision is based on
the implementation of an agreed upon set of management, operational, and
technical controls. By accrediting the system, the HSO accepts the risk
associated with it. Formalization of the accreditation process reduces the
potential that systems will be operated without appropriate management review.
Treadstone 71 recommends that re-accreditation
occur prior to a significant change in the healthcare IT system, but at least
every three years. It should be done more often where there is high risk and
potential magnitude of harm.

A significant percentage of healthcare
IT systems have not completed needed security certifications, thus placing PHI
and programs at risk and potentially impacting the viability of the healthcare
organization. Security certifications provide HSOs with the necessary
information to authorize the secure operation of those healthcare IT systems.
Currently, there are numerous competing security certification procedures
within the in the commercial marketplace that are excessively complex,
outdated, and costly to implement—resulting in assessments that are often
inconsistent, flawed, and not repeatable with any degree of confidence. There
is also a shortage of competent security expertise to conduct security
certifications on the vast inventory of healthcare IT systems. Treadstone 71:
- Developed standard guidelines
and procedures for certifying and accrediting healthcare IT systems;
- Defined essential minimum
security controls for healthcare IT systems; and
- Promotes the development of
public and private sector assessment organizations and certification of
individuals capable of providing cost effective, high quality, security
certifications based on standard guidelines and procedures.
The specific benefits of the
security certification and accreditation (C&A) initiative include:
- More consistent, comparable,
and repeatable certifications of healthcare IT systems as required by
HIPAA;
- More complete, reliable,
information for authorizing officials—leading to better understanding of
complex healthcare IT systems and associated risks and vulnerabilities—and
therefore, more informed decisions by HSOs;
- Greater availability of
competent security evaluation and assessment services; and
- More secure IT systems within
the healthcare industry complying with HIPAA regulations.
The purpose of this is to establish
standard processes, general tasks and specific subtasks to certify and accredit
healthcare IT systems supporting the healthcare organizations. While the Treadstone
71 C&A process focuses on healthcare systems processing, storing and
transmitting PHI, the associated tasks and subtasks have been broadly defined so
as to be universally applicable to all types of IT systems.
Jeff Bardin
Treadstone 71
jbardin@treadstone71.com