Authorization and HIPAA

In our last post we talked about identitification of a user at the access point: http://dallakyan.blogspot.com/2007/05/what-have-passwords-do-with-hipaa.html by use of passwords. Because of the sensitivity of patient data, users of any electronic records system who had not "proven" at the point of access that "they are who they are" must be prevented from access.

When the user had proved who he is now the question is "What can he do?" Can a valid user who had been authenticated, see EVERYTHING on EVERYONE? The users who do have authentification, must be determined by the system what data they are allowed to access and what functions can be performed by the user on that data, e.g., to view, copy, or update data. This is authorization issue. Though the differences among these questions are relatively simple, they are often confused in the literature. It is critical that any electronic health records system that implements health common framework addresses this issue.

Authorization could be user-based: that is authorization rights based on who an individual is so that he/she be associated with the audited actions; role-based; that is, the different operations available are tied to the role of the user, e.g. doctor vs. nurse vs. lab technologist vs administrative support, etc.; Context Based that is "Who you are (user) + What you are (role) + Where you are + When you are".

We do not want to prevent anyone from providing care. Authorization in many cases is based on relationship to the patient. Provider must be accountable for how that information is used or misused. Providers declare a relationship when a patient is accessed. Person-provider-activity is logged for audit.

What Have Passwords Do with HIPAA Requirements

Health Insurance Portability and Accountability Act (HIPAA) was issued to assist in the portability of health insurance and to reduce the administrative cost of healthcare. What does this have to do with medical record security?

The enhanced availability of health information in an electronic format improves the quality of and reduce the cost of health care, yet it in parrallel it arises concerns about greater risk for loss of privacy among health care participants. Meantime, one should be sure, that paper records could also be abused and misused by anyone in a white coat, and no one would ever know. At least with electronic records, there can be "audit trails," to show who has viewed at which data.

What have passwords do with protecting patient privacy and securing of health data? They control at the access point that "You are who you are". Physical attributes - signature, facial points, voice print, tping style can be used to identify who you are at the computer. Passwords are the simplest form of authentication. They can be very secure, can even be too secure – if are forgetten. Strict enforcement of "password policies" with detailed audit logs will manage user access and account activity.

Password authentification can control authentication attempts to use privileges that have not been authorized, time out on computers, require re-entry to log in.

HL7

HL7 is an international community of healthcare subject matter experts and information scientists collaborating to create standards for the exchange, management and integration of electronic healthcare information. HL7 promotes the use of such standards within and among healthcare organizations to increase the effectiveness and efficiency of healthcare delivery for the benefit of all.

"Level Seven" refers to the highest level of the ISO communication model for Open Systems Interconnection - the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. The seventh level supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations and, most importantly, data exchange structuring.

http://www.hl7.org/

Healthcare Common Procedure Coding System (HCPCS)

The Healthcare Common Procedure Coding System (HCPCS) is the standard HIPAA code sets for reporting supplies, orthotic and prosthetic devices, and durable medical equipment. In combination with the Current Procedure Terminology (CPT) codes, it is also used to report physician and other health care services.
HCPCS is one of the formats in which drugs and biologics may be coded for reimbursement and other reporting for non-retail pharmacy settings. (NDC is an alternative. The HIPAA regulations do not at present designate a single standard for this purpose.)

Unique identifiers and Enforecement rules at HIPAA

Effective May 2006 (May 2007 for small health plans), all covered entities using electronic communications (e.g., physicians, hospitals, health insurance companies, and so forth) must use a single new National Provider Identifier (NPI). The NPI replaces all other identifiers used by health plans, Medicare, Medicaid, and other government programs. The NPI does not replace a provider's DEA number however, or a provider's state license number or tax identification number. The NPI is 10 digits (not alphanumeric), the last digit being a checksum. The NPI cannot contain any embedded intelligence; in other words, the NPI is simply a number that does not itself have any additional meaning. The NPI is unique and national, never re-used, and except for institutions, a provider usually can have only one. An institution may obtain multiple NPIs for different "subparts" such as a free-standing cancer center or rehab facility.

Final Rule regarding HIPAA enforcement was issued by HHS which became effective on March 2006. The Enforcement Rule sets civil money penalties for violating HIPAA rules and establishes procedures for investigations and hearings for HIPAA violations, however its deterrent effects seems to be negligible with few prosecutions for violations

HIPAA Security Rule

The Security Rule complements the Privacy Rule. It lays out three types of security safeguards required for compliance: administrative, physical, and technical. For each of these types, the Rule identifies various security standards, and for each standard, it names both required and addressable implementation specifications.

Required specifications must be adopted and administered as dictated by the Rule. Addressable specifications are more flexible. Individual covered entities can evaluate their own situation and determine the best way to implement addressable specifications. The standards and specifications are as follows:

Administrative Safeguards - policies and procedures designed to clearly show how the entity will comply with the act:
- Covered entities must adopt a written set of privacy procedures and designate a privacy officer to be responsible for developing and implementing all required policies and procedures.
- The policies and procedures must reference management oversight and organizational buy-in to compliance with the documented security controls.
- Procedures should clearly identify employees or classes of employees who will have access to protected health information (PHI). Access to PHI in all forms must be restricted to only those employees who have a need for it to complete their job function.
- The procedures must address access authorization, establishment, modification, and termination.
- Entities must show that an appropriate ongoing training program regarding the handling of PHI is provided to employees performing health plan administrative functions.
Covered entities that out-source some of their business processes to a third party must ensure that their vendors also have a framework in place to comply with HIPAA requirements. Companies typically gain this assurance through clauses in the contracts stating that the vendor will meet the same data protection requirements that apply to the covered entity. Care must be taken to determine if the vendor further out-sources any data handling functions to other vendors and monitor whether appropriate contracts and controls are in place.
- A contingency plan should be in place for responding to emergencies. Covered entities are responsible for backing up their data and having disaster recovery procedures in place. The plan should document data priority and failure analysis, testing activities, and change control procedures.
- Internal audits play a key role in HIPAA compliance by reviewing operations with the goal of identifying potential security violations. Policies and procedures should specifically document the scope, frequency, and procedures of audits. Audits should be both routine and event-based.
Procedures should document instructions for addressing and responding to security breaches that are identified either during the audit or the normal course of operations.

Physical Safeguards - controlling physical access to protect against inappropriate access to protected data
- Controls must govern the introduction and removal of hardware and software from the network. (When equipment is retired it must be disposed of properly to ensure that PHI is not compromised.)
- Access to equipment containing health information should be carefully controlled and monitored.
- Access to hardware and software must be limited to properly authorized individuals.
- Required access controls consist of facility security plans, maintenance records, and visitor sign-in and escorts.
- Policies are required to address proper workstation use. Workstations should be removed from high traffic areas and monitor screens should not be in direct view of the public.
- If the covered entities utilize contractors or agents, they too must be fully trained on their physical access responsibilities.

Technical Safeguards - controlling access to computer systems and enabling covered entities to protect communications containing PHI transmitted electronically over open networks from being intercepted by anyone other than the intended recipient
- Information systems housing PHI must be protected from intrusion. When information flows over open networks, some form of encryption must be utilized. If closed systems/networks are utilized, existing access controls are considered sufficient and encryption is optional.
- Each covered entity is responsible for ensuring that the data within its systems has not been changed or erased in an unauthorized manner.
- Data corroboration, including the use of check sum, double-keying, message authentication, and digital signature may be used to ensure data integrity.
- Covered entities must also authenticate entities it communicates with. Authentication consists of corroborating that an entity is who it claims to be. Examples of corroboration include: password systems, two or three-way handshakes, telephone callback, and token systems.
- Covered entities must make documentation of their HIPAA practices available to the government to determine compliance.
- In addition to policies and procedures and access records, information technology documentation should also include a written record of all configuration settings on the components of the network because these components are complex, configurable, and always changing.
- Documented risk analysis and risk management programs are required. Covered entities must carefully consider the risks of their operations as they implement systems to comply with the act. (The requirement of risk analysis and risk management implies that the act’s security requirements are a minimum standard and places responsibility on covered entities to take all reasonable precautions necessary to prevent PHI from being used for non-health purposes.)

HIPAA Transactions and Code Sets Rule

The HIPAA Electronic Data Exchange (EDI) provision was scheduled to take effect in October 2003. Due to widespread confusion and difficulty in implementing the rule one-year extension was granted by Centers for Medicare & Medicaid Services (CMS), but since in one year full implementation was not achieved an open-ended "contingency period" started. Penalties for non-compliance were not levied; however, all parties are expected to make a "good-faith effort" to come into compliance. (see http://www.cms.hhs.gov/TransactionCodeSetsStands/02_TransactionsandCodeSetsRegulations.asp#TopOfPage).

The code sets represent Current Procedural Terminology (CPT) codes (https://catalog.ama-assn.org/Catalog/cpt/cpt_home.jsp), International Classification of Diseases (ICD) (http://www.who.int/classifications/icd/en/index.html), National Drug Code (NDC) (http://www.fda.gov/cder/ndc/).

http://www.wpc-edi.com/products/codelists/alertservice