[Med-privacy] ITL Bulletin for April 2005

Jeff Williams jwkckid1@ix.netcom.com
Mon, 25 Apr 2005 22:47:14 -0700


All,

  FYI:

ITL BULLETIN for April 2005

IMPLEMENTING THE HEALTH INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT (HIPAA) SECURITY RULE
By Joan S. Hash
Computer Security Division
Information Technology Laboratory
National Institute of Standards and Technology
Technology Administration
U.S. Department of Commerce

Introduction
To assist federal agencies with implementing the security
standards required by the Health Insurance Portability and
Accountability Act (HIPAA), NIST’s Information Technology
Laboratory released NIST Special Publication (SP) 800-66,
An Introductory Resource Guide for Implementing the Health
Insurance Portability and Accountability Act (HIPAA)
Security Rule. This ITL Bulletin summarizes the special
publication.

Background
The Health Insurance Portability and Accountability Act
(HIPAA) of 1996 (Public Law 104-191) defines security
standards to be adopted for the protection of electronic
protected health information (EPHI). These standards, known
as the HIPAA Security Rule, were published by the Secretary
of Health and Human Services (HHS) on February 20, 2003.

Purpose and Applicability
NIST SP 800-66 summarizes the HIPAA security standards and
explains some of the structure and organization of the
Security Rule. The publication helps to educate readers
about information security terms used in the HIPAA Security
Rule and to improve understanding of the meaning of the
security standards set out in the Security Rule.

Special Publication 800-66 is also designed to direct
readers to helpful information in other NIST publications
on individual topics addressed by the HIPAA Security Rule.
Readers can draw upon these publications for consideration
in implementing the Security Rule.

Figure 1. shows all of the components of HIPAA and
illustrates that the focus of NIST SP 800-66 is on the
security provisions of the statute and the regulatory rule.
(Figure not provided in e-mail version of bulletin, see
NIST SP 800-66.)

“Covered entities” (except small health plans) must comply
with the final Security Rule by April 21, 2005, and small
health plans must comply by April 21, 2006.1 Readers should
refer to the Centers for Medicare and Medicaid Services
(CMS) website, http://www.cms.hhs.gov/hipaa/hipaa2, for
more detailed information about the passage of HIPAA by
Congress, specific provisions of HIPAA, determination of
the entities covered under the law, the complete text of
the HIPAA Security Rule, the deadline for compliance with
the Rule, and enforcement information.

The HIPAA Security Rule
The HIPAA Security Rule specifically focuses on the
safeguarding of EPHI. Although the Federal Information
Security Management Act (FISMA) applies to all federal
agencies and all information types, only a subset of
agencies is subject to the HIPAA Security Rule based on
their functions and use of EPHI. All HIPAA covered
entities, which includes some federal agencies, must comply
with the Security Rule. The Security Rule specifically
focuses on protecting the confidentiality, integrity, and
availability of EPHI, as defined in the Security Rule. The
EPHI that a covered entity creates, receives, maintains, or
transmits must be protected against reasonably anticipated
threats, hazards, and impermissible uses and/or
disclosures. In general, the requirements, standards, and
implementation specifications of the Security Rule apply to
the following covered entities:
* Covered Health Care Providers­ Any provider of medical or
other health services or supplies, who transmits any health
information in electronic form in connection with a
transaction for which HHS has adopted a standard.
* Health Plans­ Any individual or group plan that provides
or pays the cost of medical care (e.g., a health insurance
issuer and the Medicare and Medicaid programs).
* Health Care Clearinghouses­ A public or private entity
that processes another entity’s health care transactions
from a standard format to a nonstandard format, or vice versa.
* Medicare Prescription Drug Card Sponsors – A
nongovernmental entity that offers an endorsed discount
drug program under the Medicare Modernization Act. This
fourth category of “covered entity” will remain in effect
until the drug card program ends in 2006.

Security Rule Goals and Objectives
As required by the “Security standards: General rules”2
section of the HIPAA Security Rule, each covered entity must:
* Ensure the confidentiality, integrity, and availability
of EPHI that it creates, receives, maintains, or transmits;
* Protect against any reasonably anticipated threats and
hazards to the security or integrity of EPHI; and
* Protect against reasonably anticipated uses or
disclosures of such information that are not permitted by
the Privacy Rule.

Security Rule Organization
To understand the requirements of the HIPAA Security Rule,
it is helpful to be familiar with the basic security
terminology it uses to describe the security standards. By
understanding the requirements and the terminology in the
HIPAA Security Rule, it becomes easier to see which NIST
publications may be appropriate reference resources and
where to find more information. The Security Rule is
separated into six main sections that each include several
standards and implementation specifications a covered
entity must address.3 Each of the six sections is listed below.
* Security standards: General Rules includes the general
requirements all covered entities must meet; establishes
flexibility of approach; identifies standards and
implementation specifications (both required and
addressable); outlines decisions a covered entity must make
regarding addressable implementation specifications; and
requires maintenance of security measures to continue
reasonable and appropriate protection of electronic
protected health information.
* Administrative Safeguards are defined in the Security
Rule as the “administrative actions and policies, and
procedures, to manage the selection, development,
implementation, and maintenance of security measures to
protect electronic protected health information and to
manage the conduct of the covered entity's workforce in
relation to the protection of that information.”
* Physical Safeguards are defined as the “physical
measures, policies, and procedures to protect a covered
entity's electronic information systems and related
buildings and equipment, from natural and environmental
hazards, and unauthorized intrusion.”
* Technical Safeguards are defined as “the technology and
the policy and procedures for its use that protect
electronic protected health information and control access
to it.”
* Organizational Requirements includes standards for
business associate contracts and other arrangements,
including memoranda of understanding between a covered
entity and a business associate when both entities are
government organizations, and requirements for group health
plans.
* Policies and Procedures and Documentation Requirements
requires implementation of reasonable and appropriate
policies and procedures to comply with the standards,
implementation specifications, and other requirements of
the Security Rule; maintenance of written (which may be
electronic) documentation and/or records that includes
policies, procedures, actions, activities, or assessments
required by the Security Rule; and retention, availability,
and update requirements related to the documentation.

Within the Security Rule sections are standards and
implementation specifications. Each HIPAA Security Rule
standard is required. A covered entity is required to
comply with all standards of the Security Rule with respect
to all EPHI. Many of the standards contain implementation
specifications. An implementation specification is a more
detailed description of the method or approach covered
entities can use to meet a particular standard.4
Implementation specifications are either required or
addressable. However, regardless of whether a standard
includes implementation specifications, covered entities
must comply with each standard.
* A required implementation specification is similar to a
standard, in that a covered entity must comply with it.
* For addressable implementation specifications, covered
entities must perform an assessment to determine whether
the implementation specification is a reasonable and
appropriate safeguard for implementation in the covered
entity’s environment.

Table 2.  HIPAA Security Rule Standards and Implementation
Specifications5 (table not included in e-mail version of
bulletin, see NIST SP 800-66)
Conclusion
NIST SP 800-66 includes both a mapping of the HIPAA
Security Rule standards to supporting NIST publications,
which can be used to assist with the HIPAA Security Rule
implementation, and a mapping of HIPAA requirements to the
Federal Information Security Management Act (FISMA)
requirements. It is a valuable resource for federal
agencies subject to compliance with both pieces of
legislation. The document is available at
<http://csrc.nist.gov/publications/nistpubs/index.html>http://csrc.nist.gov/publications/nistpubs/index.html.

Footnotes:
1 The definition of “small health plan” at 45 CFR § 160.103
applies to all of the HIPAA rules, including the Security
Rule.  A “small” health plan is one with annual receipts of
$5 million or less.

2 See 45 C.F.R. § 164.306(a).

3 Sections of the HIPAA regulations that are included in
the Security Rule and therefore addressed in this document
but do not have their own modules are Part 160 ­ General
Administrative Requirements § 160.103, Definitions; Part
164 ­ Security and Privacy §§ 164.103, Definitions;
164.104, Applicability; 164.105, Organizational
requirements (discussed in section 4 of this document),
164.302 Applicability; 164.304, Definitions; 164.306,
Security standards: General rules (discussed in section 3.1
of this document), and 164.318, Compliance dates for the
initial implementation of the security standards.

4 For more information on the required analysis used to
determine the manner of implementation of an implementation
specification, see § 164.306(d) of the HIPAA Security Rule
(Security standards ­ General rules: Flexibility of approach).

5 Adapted from 68 Federal Register 8380, February 20, 2003
(Appendix A to Subpart C of Part 164--Security Standards:
Matrix).

Disclaimer: Any mention of commercial products or reference
to commercial organizations is for information only; it
does not imply recommendation or endorsement by the
National Institute of Standards and Technology nor does it
imply that the products mentioned are necessarily the best
available for the purpose.


Elizabeth B. Lennon
Writer/Editor
Information Technology Laboratory
National Institute of Standards and Technology
100 Bureau Drive, Stop 8900
Gaithersburg, MD 20899-8900
Telephone (301) 975-2832
Fax (301) 840-1357


Regards,

--
Jeffrey A. Williams
Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!)
"Be precise in the use of words and expect precision from others" -
    Pierre Abelard

"If the probability be called P; the injury, L; and the burden, B;
liability depends upon whether B is less than L multiplied by
P: i.e., whether B is less than PL."
United States v. Carroll Towing  (159 F.2d 169 [2d Cir. 1947]
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