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What it does 

The 2017 Interoperability Standards Advisory (ISA) is a catalog of standards and implementation specifications (i.e., additional instructions for implementing standards) that are used in healthcare-related information technology (IT), in order to meet interoperability needs. Interoperability is defined as the ability of two or more systems to exchange information and the ability of those systems to use the information that has been exchanged without special effort. Ultimately, the goal of the ISA is “to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes.”

The 2017 ISA is the latest iteration of an annually updated advisory produced by the Office of the National Coordinator for Health Information Technology (ONC). Its specific stated purposes are to:

  • Provide “a single, public list of the standards and implementation specifications that can best be used to address specific clinical health information interoperability needs.” ISA’s current main focus is on interoperability between entities rather than within entities.   
  • Highlight the results of ongoing conversation, mediated through public comment, between stakeholders in regards to situations where more than one standard or implementation specification can be used to serve a single need.
  • Cite “limitations, preconditions, and dependencies,” and suggest best practices for security.

The 2017 advisory features updates and improvements to the 2016 advisory derived largely from public comments and the work of the Health IT Standards Committee. Some of the changes are:

  • The focus of the ISA has expanded to more explicitly include public health and health research interoperability.
  • The ONC has also discontinued the use of the phrase “best available” based on stakeholder feedback. Instead they will use the advisory to identify standards and implementation specifications to increase public awareness.
  • A published advisory document, called a “Reference Edition”, will still be released once annually, but the online ISA will provide close to real-time updates and ongoing public comment opportunities.

Listed below are the six “informative characteristics” used to describe each interoperability standard or implementation specification:

  • Standards Process Maturity – the stage of development of the standard
  • Implementation Maturity – whether the standard is in pilot mode or production
  • Adoption Level – how broadly the standard is adopted for the relevant need
  • Federally Required – whether the standard is federally required
  • Cost – any fees associated with the standard
  • Test Tool Availability – availability of a tool for testing conformance to the standard

The 2017 ISA lists standards and implementation specifications for several interoperability needs that are related to genetics and genomics as well as neuroscience. These include standards and implementation specifications for the following:

Furthermore, the ISA includes links to ONC’s Interoperability Proving Ground to “showcase real-world implementations of standards listed within the ISA.” And Appendix I of the 2017 advisory addresses necessary security standards and security patterns associated with interoperability needs. Finally, the ISA lists questions and requests for stakeholder feedback to facilitate discussion for the next ISA updates.

Relevant Science 

Interoperability, the meaningful sharing of electronic health information between platforms, is seen as critical for the future of healthcare and healthcare-related fields. As the amount and variety of the average patient’s health information inevitably grows, so do the challenges of transmitting and interpreting that information.

Genetic tests, which are lab tests used to detect an individual’s genetic variants, are becoming more common and complex. Genetic variants contribute to the diversity of human appearance (eye color, height, etc.), but they also determine a person’s susceptibility to a number of disorders. Some disorders can be caused by a single mutation, while other disorders might have more complex genetic factors. Scientists have developed a number of genetic tests to detect if a patient has a known disease-causing or -associated genetic variants – these typically only examine one or a few of the more than 20,000 genes found in the human genome (the total DNA found in a human cell). However, technological advancements have opened the door for large-scale genetic tests that screen large portions or even the entirety of a patient’s genome for genetic variants.

A patient’s family health history can be used to identify diseases that run in the patient’s family. The presence of such patterns often indicates an underlying genetic factor. If the genetic factor is identified, further genetic testing can determine whether or not the patient has inherited the factor and is thus genetically predisposed to the disease in question. And if the patient is found to have the genetic factor, they might be able to take preventative steps to slow or prevent disease onset.

Interoperability is fundamental for a lot of clinical research efforts, to include national health initiatives such as the Precision Medicine Initiative and the Cancer Moonshot Initiative. These initiatives make use of data from multiple sources and disciplines including genetic testing, family health history, medical imaging, and other health information, to look for factors (e.g. genetic) that lead to various diseases, such as cancer or neurodegenerative disorders.

Endorsements & Opposition 

Endorsements:

  • Personal Connected Health Alliance applauded ONC to include Continua Design Guidelines in the 2017 ISA, “This marks an important milestone, not just for the Continua Design Guidelines, but for the betterment of patient care."
  • American Hospital Association: “The ISA is a key step toward achieving the goals we have outlined with our public and private sector partners in the Shared Nationwide Interoperability Roadmap, as well as the Interoperability Pledge announced earlier this year.” 
  • Centers for Medicaid and Medicare Services: “We are deadly serious about interoperability. We will begin initiatives in collaboration with physicians and consumers toward pointing technology to fill critical use cases like closing referral loops and engaging a patient in their care. And technology companies that look for ways to practice ‘data blocking’ in opposition to new regulations will find that it won’t be tolerated.” Andy Slavitt

Opposition:

  • Becker Hospital Review, Dr. Golder: "All of the rules and initiatives that are proposed in the roadmap are going to result in additional standards and governance, measurement and oversight from ONC. This really represents a tremendous amount of new regulations and new standards. It may make meaningful use pale by comparison."
Status 

ONC released its annual 2017 non-binding Interoperability Standards Advisory on December 20th, 2016. The comment period on the 2017 draft – published on August 22nd, 2016 – ended on Monday, October 24, 2016.

Primary Author 
Hira Ahmed, MA Candidate
Editor(s) 
Nicole Angelica, MA Candidate; Alex Robeson, PhD
Recommended Citation 

Duke SciPol, “Office of the National Coordinator for Health Information Technology’s 2017 Interoperability Standards Advisory” available at  (06/16/2017).

License 
Creative Commons License This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Please distribute widely but give credit to Duke SciPol and the primary author(s) listed above, linking back to this page if possible.