How to participate in AAD’s DataDerm™ clinical data registry

By Allyn Rosenberger, JD, MPH, Ben Tesdahl, JD, LL.M, and Robert M. Portman, JD, MPP, September 1, 2023

Every month, DermWorld covers legal issues in “Legally Speaking.” This month’s authors are health care attorneys with Allyn Rosenberger, JD, MPH, Ben Tesdahl, JD, LL.M, and Robert M. Portman, JD, MPP. Portman is also general counsel for the AAD and AADA.


DataDerm was created in 2016 by the American Academy of Dermatology (AAD) and has grown to become dermatology’s largest clinical data registry. Joining DataDerm carries with it several benefits, including helping physicians assess and optimize care, improve practice efficiency, avoid penalties, and facilitate research and development. Participating in DataDerm is relatively easy, and the DataDerm website contains a very useful FAQ page that covers many of the common questions physicians have about DataDerm. However, there are some contractual obligations and other requirements that must be followed, and those are outlined below.   

Who can participate in DataDerm?

First and foremost, a person must be an active member of the AAD in the United States in order to participate in and use the DataDerm registry, since it is a members-only AAD benefit. However, nurse practitioners and physician assistants can participate if they work in a practice that is majority AAD members.

What are the steps to join DataDerm?

There are three basic steps to participate in DataDerm, and those simple steps are outlined on the AAD website. First, participants will be asked to verify whether their EHR will integrate with DataDerm. DataDerm integrates with more than 30 EHR vendors. Second, participants will be asked to complete the DataDerm sign-up portal, using their AAD membership ID and password. Finally, at the end of the sign-up process, participants will be asked to review and sign the DataDerm Participation Agreement and a combined Business Associate/Data Use Agreement (BAA/DUA), both of which may be submitted electronically through the sign-up portal or downloaded and emailed to dataderm@aad.org.   

The Participation Agreement sets forth the terms for a dermatology practice’s participation in DataDerm. It requires participants to submit data to DataDerm in exchange for the many benefits of participating in the registry that are described below. Participants retain ownership of the data they submit to DataDerm, but give AAD broad permission to use, aggregate, and analyze their data for certain quality improvement and research purposes. The AAD owns the databases, data dictionaries, data fields, and other elements of the registry, subject to the rights of participants in their data.

The Participation Agreement requires the AAD and its database vendor to protect participants’ data in accordance with all applicable statutes and regulations concerning patient privacy and data security, including but not limited to the regulations issued under the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA). As physicians or groups of physicians, all DataDerm participants are “covered entities” under the HIPAA regulations, and AAD is considered a “business associate” of each participant because it performs quality improvement functions and services for its participants. As a business associate, the AAD and its sub-business associate database vendor must comply with all the HIPAA requirements for such entities.

To that end, participants must review and sign DataDerm’s combined BAA/DUA. This agreement specifies in detail the steps that the AAD and its database vendor must take to protect the privacy and security of participants’ data, as well as the purposes for which AAD can use participants’ “protected health information” (PHI) as defined by HIPAA.

The BAA/DUA also contains provisions that permit AAD to create “limited data sets” from the PHI it collects from participants. HIPAA defines limited data sets as PHI that exclude most patient identifiers except:

• dates such as admission, discharge, service, DOB, DOD;

• city, state, five digit or more ZIP code; and

• ages in years, months, or days or hours.

The DUA portions of the BAA/DUA allow the AAD to create and use limited data sets for research, public health, and health care operations (e.g., quality improvement) purposes. The AAD can also share limited data sets with third parties for these purposes if they sign a DUA that meets the HIPAA requirements for such agreements.

Both the Participation Agreement and the BAA/DUA must be executed before a dermatology practice or department can participate in DataDerm.

DataDerm benefits to participants

Participation in DataDerm allows participants to benefit from the information from the DataDerm database, which includes data on dermatologic procedures and treatments for more than 13 million dermatology patients. Participants are entitled to receive electronic access to AAD data entry and review forms; reports and graphical dashboards, each of which will include both aggregated data from the DataDerm and participant-specific information; and such other reports as the AAD or its independent service providers may prepare. All reports are structured to reflect data of the participant, as directed by the participant in a written request. Additional reports may be created for the participant in return for an additional fee.    

To request DataDerm data for a research or quality improvement initiative, participants simply complete the data request form on the AAD’s website, at which point a member of the DataDerm team will reach out via email to confirm the request.

In addition, participants benefit from the data analyses, quality assessments, and research that the AAD conducts using DataDerm data to the extent that these activities lead to improved quality of care and patient outcomes from dermatologic treatments and procedures.

Lastly, participants can meet their data submission requirements under the Merit-based Incentive Payment System (MIPS) by reporting through DataDerm’s Qualified Clinical Data Registry (QCDR). DataDerm participants have been successful in avoiding penalties by choosing quality measures found only in DataDerm.

The DataDerm website also contains a wealth of additional information, including a resource page with a sign-up training guide, an administrator access guide, and information on MIPS and QCDR measures.

Examples of DataDerm research

DataDerm data has been used in several research projects, many of which have been published or will soon be published. They include a summary of results of a 2020 independent audit of DataDerm’s completeness and accuracy (published in the JAAD), three annual summaries of DataDerm initiatives and data (also published in JAAD), an article on the demographics of patients with pyoderma gangrenosum (published in Wound Repair and Regeneration), an article on the demographics of patients with Sweet syndrome (published in Dermatology), and a poster abstract and future article on the demographics of patients with vitiligo.

Conclusions

Dermatology practices should seriously consider participating in DataDerm to take advantage of its many benefits. The contractual and other legal aspects of such participation are intended to protect the confidentiality of participant data while also acknowledging and preserving participants’ ownership and control of their data.

This article is provided for informational and educational purposes and is not intended to provide legal advice and should not be relied upon as such. Readers should consult with their personal attorneys for legal advice regarding the subject matter of this article.

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