A registry is an organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons who have either a particular disease, a condition (e.g., a risk factor) that predisposes to the occurrence of a health-related event, or prior exposure to substances (or circumstances) known or suspected to cause adverse health effects. There are registries for many diseases, conditions and events (i.e. cancer, lead poisoning, toxic shock syndrome, influenza and birth defects including Down's syndrome). Without these registries, it would be impossible to understand the magnitude of a health problem. Understanding the magnitude of a disease or condition is important for several reasons. While rare diseases are just as important as those more commonly seen, those affecting the most people will receive the most research and treatment attention. When a disease or condition begins to increase across a population, scientists must know who the increases are affecting and where the increases are so they can begin to understand what might be causing it and what might treat it. And, a registry can show if diseases or conditions are decreasing and what affect treatments may be having.

The WV Autism Training Center (WVATC) is a statewide service delivery program. Anyone with a diagnosis of an autism spectrum disorder residing in the state of West Virginia can apply for and receive education and training services from the staff at the WVATC. These families “register” for services and receive a registry card that entitles them to access a variety of direct training services and many resource services. The WV Autism Spectrum Disorders (WVASD) Registry is not related to services at all. While it is housed at and operated by the WV Autism Training Center, it is just a way to track how many new cases of an ASD are diagnosed each year.

If I am a registered family with WVATC, am I automatically in the WVASD registry?

No . They are two separate things. Families do not enter their children into the WVASD registry. That is the responsibility of the diagnostician. Families may choose to register for the services offered by the WV Autism Training Center. Only the family can refer or register themselves for these services. It is completely voluntary. Services provided by the center are free for families. To learn more about the services offered by the WV Autism Training Center and how to register for services, visit their website.

Why is there a need for a registry for autism spectrum disorders?

We really do not know how many people in the United States have an autism spectrum disorder. We can say with some certainty, that there are more than the 5 in 10,000 (autism) and 15 in 10,000 (all autism spectrum disorders) that has been reported from the 1970's through 2002. Studies from California suggested a 273% increase from 1987 to 1998. This alarming number drew the attention of the media and of Congress as well. In 2001, Congressman Chris Smith (R-New Jersey) stated that “it is not an exaggeration to say that autism is the silent epidemic of our time…it is silent because there are currently no operational autism registries in the nation to tell us how many people actually have autism.”

The WVASDR is the first registry for autism spectrum disorders in the nation. This registry will be invaluable in telling us how many people in West Virginia receive an autism diagnosis year by year. We will be able to understand and inform policy makers and the public of the magnitude of this syndrome. This is the primary purpose of the WVASDR.

Will the name of the individual with an autism spectrum disorder appear in the registry?

No . Names are not being collected. They are not needed to know how many people have this syndrome. We do need to ensure that we do not enter a person twice (if they receive a diagnosis by two or more diagnosticians). We are asking the person reporting to use a designated standard method of coding for the cases that will allow the names to remain confidential.

How can an autism spectrum disorders registry help individuals with autism and their families?

Since autism has been thought to be a low incidence condition, funds have not been adequately appropriated to find its cause or treatment. Guesses at the prevalence and incidence of ASD's do not merit the attention of the Federal Government. They need to see data. The ASD Registry data can have an impact at the Federal and State Funding levels for education in public schools, for treatment funding, for adult funding issues and for a variety of other needed services for each individual with an ASD.

Are there other purposes for the WVASDR?

The data collected can help researchers at the WV Autism Training Center and their colleagues understand more about a variety of factors concerning the incidence of autism spectrum disorders. In public health and medicine, there are many uses for the information collected in registries. In addition to estimating the magnitude of a problem or the prevalence of a disease or condition, other purposes include:

Determining the incidence of disease: For instance, registries that collect information on all cases of brain cancer within a defined region are used to calculate tumor specific cancer-rates, information that can be used for investigating suspected cancer clusters (a higher than expected number of cancer cases in a specific geographic region). The WVASDR will be able to look at geographic locations (by county only) to see if there are higher than expected numbers of individuals with an autism spectrum disorder in that region. Researchers would then begin to look at any possible factors to explain the cluster.

Examining trends of disease over time: For instance, registry data have documented the rapid increase in the occurrence among women of lung cancer, now the most frequent cause of cancer in this group. The WVASDR will be able to monitor the number of males versus females with an ASD as well as the number of specific type of ASD reported.

 

How will the information collected in the WVASDR be used?

Primarily, the total number of new cases of autism spectrum disorders diagnosed each year will be shared with a variety of agencies that need this information for planning for services for this population. Among these agencies are the WV Department of Education, Office of Special Education and the Office of Behavioral Health. Since autism spectrum disorders have been considered to be a low incidence condition, funding for the necessary educational and behavioral services has been allocated accordingly. No individual data will ever be reported. Any results reported will be across a group of individuals.

Yes, this ASD registry is legal. Autism spectrum disorders are named a reportable condition in West Virginia State Code: Legislative Rule, Title 64, Series 7, Category 11A (3.5.b.2). This legislative rule “establishes procedures governing the reporting of certain diseases and conditions, unusual health events, and clusters or outbreaks of diseases to the division of health.” The rule is enforced by the commissioner of the West Virginia bureau for public health or his or her lawful designee. The W.Va. code is available in public libraries and on the legislature's web page.

Will the families of those in the registry ever be contacted for more information or about participation in research because they are in the registry?

No. There would be no way to know who to contact. We do not collect name, address or phone number.

How is an individual reported to the registry?

If a medical doctor, psychiatrist or licensed psychologist makes a diagnosis of autism, pervasive developmental disorder not otherwise specified, Asperger's syndrome, Rett's syndrome or childhood disintegrative disorder, that diagnostician completes a registry report form. The diagnostician indicates what the diagnosis is, if there are any other conditions present and notes what behavioral symptoms were present using the Diagnostic and Statistical Manual – IV –TR (DSM IV-TR) criteria for the condition. Any known medications are also reported.

Are private practice physicians required to report new ASD cases?

Yes, in compliance with state reporting regulations

If an individual receives an ASD diagnosis from a facility outside of West Virginia , must that individual be reported to the WV ASD registry?

Yes. Anyone who resides in West Virginia and has a diagnosis of ASD must be reported to the WV ASD Registry after January 1, 2004 , regardless of where they received the diagnosis. (See also question # 16)

How can a family be sure that confidentiality will be protected?

Confidentiality is a priority. No names are collected and there is no information that would enable anyone to trace the reporting information to a specific individual. In addition, the database that stores the registry information is completely secure and requires two pass codes for authorized personnel to enter it.

How does the WVASDR comply with HIPAA?

Registries are considered public health authorities because their duties are mandated by state laws.

What is a ‘public health authority' under HIPAA?

Under HIPAA, a ‘Public Health Authority' refers to “an agency or authority of the United States, a State or territory, a political subdivision of a State or territory, or an Indian tribe, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.”(1) “...Such agencies are authorized by law to collect or receive such information for the purposes of preventing or controlling disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.” (2)

(1) C.F.R. 164.501
(2) C.F.R. 164.512

 

What is a ‘covered entity' under HIPAA?

A ‘ Covered Entity' is a health care plan, a healthcare clearinghouse, or a health care provider who transmits any health information in electronic form for financial and administrative transactions. A ‘health care provider' is “a provider of medical or health services, and any other person who furnishes, bills or is paid for health care in the normal course of business.”(1)

(1) C.F.R. 160.103

 

No. HIPAA does not obstruct any state law that supports or mandates the reporting of diseases or injury for public health purposes.

If the government–authorized public health entity is not located in the same state as the covered entity, is it still ok under HIPAA to provide the data?

Yes. In fact, the definition of a ‘public health entity' was broadened in the section “Uses and Disclosures for Public Health Activities”, which states specifically “…We broaden the scope of allowable disclosures …by allowing covered entities to disclose protected health information not only to U.S. public health authorities but also, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority.”1, 2 1 F.R. p. 82525 2 45 C.F.R. 164.512

Yes, tracking (also called surveillance) programs can show how many people in a defined population and geographic area have a condition at a given time. For example, the CDC studied how many 3 to 10 year olds in metro Atlanta had autism in the calendar year 1996. They found that 34 in 10,000 had the disorder (significantly higher than the previously reported prevalence rate of 5 in 10,000. This alarming difference caught the attention of the U.S. Congress who charged the CDC with the task of providing collaborative agreements to other states to conduct similar monitoring systems. West Virginia was the first state to join the CDC to monitor autism in 2000.

The multiple source monitoring system used in the CDC study is extremely time intensive and can be costly over time. The same method must be implemented in subsequent years to look at any trends. For example, the CDC has recently completed tracking children with ASD who were 3 to 10 years old in the year 2000. They will compare with the 34 in 10,000 they found in their previous study of children who were 3 to 10 years old in the year 1996. The ASD monitoring system cannot reveal how many new individuals were given a diagnosis in a given year. The WVASDR WILL be able to show how many new cases of an ASD were diagnosed during the year 2004 and forward. And, if there are more and more new cases diagnosed each year, researchers must look to understand why. In addition, the WVASDR will be much less costly than multiple source surveillance. Since the diagnosticians need only to complete a reporting form and send it in to the registry, the cost to operate the WVASDR is far different from the cost of an active tracking system which entails travel and many hours of record review and abstraction.