Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

by DLA Piper

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the National Coordinator for Health IT (ONC) have released a draft report outlining a proposed strategy and recommendations for a “risk based” regulatory framework for health information technology.i  

Mandated by Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA),ii the draft report was released amidst stakeholder calls for additional clarity on how the federal government will regulate the health IT industry – an industry that has seen significant growth in recent years due to the incentives for adoption and use of electronic health records (EHRs) offered under the HITECH Act, as well as the use of technology to support emerging payment and delivery models.

This draft report is likely one in a series of guidance documents and regulations that will shape the federal government’s footprint in this space over the years to come. It outlines a number of opportunities for private sector stakeholders to engage with the agencies as they continue to shape their policies and thinking in this space and may also inform subsequent legislative efforts.

A brief overview of the agencies’ draft report is below. Although the FDA provided some clarity regarding its regulatory intent, there are still many unanswered questions regarding the ONC-led non-regulatory initiatives recommended for health management health IT or “clinical software.”

“Risk-based” regulatory framework

A key conclusion of the draft report is that “no new or additional areas of FDA oversight are needed” at this time – a decision that private sector stakeholders have applauded since the report’s release.  Instead, the agencies proposed to leverage existing regulatory and non-regulatory mechanisms where possible and necessary, basing their specific recommendations on the type of health IT and its functionality.iii

To create the framework outlined in the draft report, the agencies divided health IT into three broad categories: administrative, health management and medical device health IT. The suggested approach for promoting patient safety and innovation across these categories spanned the spectrum of regulatory action, with the agencies recommending no oversight for administrative health IT on one hand and continued FDA regulation of medical device health IT under the Food, Drug and Cosmetic Act (FD&C Act) on the other.

A more nuanced, non-regulatory framework was recommended for the third category of health IT, so-called “clinical software” or health management health IT. For this category, the agencies recommended a “limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities.” The agencies outline a number of suggested strategies and priority areas in the draft report, including tactics that “foster the development of a culture of safety and quality; leverage standards and best practices; employ industry-led testing and certification; and selectively use tools such as voluntary listing, reporting and training to enable the development of a healthcare environment that is transparent and promotes learning to foster continual health IT improvement.”

Opportunities for  industry participation

While the draft report outlines a number of areas where the agencies – particularly ONC – intend to take action, it also highlights a number of specific opportunities for private sector engagement and indicates that industry participation in priority areas “could help … avoid the need for a more active regulatory approach…” in the future.

Specifically, the draft report indicates that there may be an opening for non-governmental, private sector entities to assist in creating accountability and transparency across the health IT industry by:

  • Developing tests to validate the interoperability, test product conformance with standards, and transparently share results of product performance to promote broader adoption of interoperable solutions
  • Implementing and applying voluntary conformity assessment tools, such as certification, product testing, and accreditation, to selected health IT products in a risk-based manner and
  • Maintaining and making available to consumers a voluntary, publicly accessible list of certain types of health management health IT products.

In addition, the agencies recommend the creation of a public-private Health IT Safety Center to “serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” HHS requested $5 million in its FY2015 President’s Budget Request to fund the center.

Clinical decision support 

As technology advances, clinical decision support (CDS) tools are increasingly used to electronically “provide health care providers and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.” These tools range from highly sophisticated tools that run advanced algorithms and analytics to determine what information to present to a provider to more rudimentary technologies such as a PDF file listing appropriate care guidelines for a certain condition.

Despite the framework outlined in the report, the regulatory structure for some CDS tools remains unclear. Although the agencies indicate that the FDA will not focus its oversight on health management health IT with functionality that meets the definition of a “medical device” under the FD&C Act, they also state that FDA is currently - and will remain - focused on “health IT with medical device functionality.”

While “most” CDS functionality is classified as health management health IT and thus subject to the non-regulatory framework outlined in the report, as outlined below, a subset of CDS software that “presents higher risks” is  subject to regulation under the FD&C Act as medical device health IT.

Examples of CDS that are subject to non-regulatory framework as “health management health IT”

“Most” CDS, including:

  • Evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference
  • Drug-drug interaction and drug-allergy contraindication alerts to avert adverse drug events
  • Most drug dosing calculations
  • Drug formulary guidelines
  • Reminders for preventative care
  • Facilitation of access to treatment guidelines and other reference material that can provide information relevant to particular patients
  • Calculation of prediction rules and severity of illness assessments
  • Duplicate testing alerts
  • Suggestions for possible diagnoses based on patient-specific information retrieved from a patient’s EHR


Examples of CDS that are classified as “medical device health IT” and subject to continued FDA oversight under the FD&C Act

  • Computer aided detection/diagnostic software
  • Remote display or notification of real-time alarms (physiological, technical, advisory) from bedside monitors
  • Radiation treatment planning
  • Robotic surgical planning and control
  • Electrocardiography analytical software


The draft report indicates that FDA intends to work with stakeholders “to clarify the types of medical device [CDS] that should be the focus of FDA’s oversight.”

Moving forward

The regulatory framework for health IT will continue to evolve as technology is cemented as the foundation for care delivery and payment reform. Interested stakeholders should consider providing feedback to the agencies through a variety of mechanisms, including submitting comments and participating in public meetings. Robust stakeholder participation is essential to ensure that new federal health IT initiatives reflect technological advancements, emerging market trends and new payment and delivery models.

[i]               “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework.” Available here.

[ii]               Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-144.

[iii]              Because the agencies used functionality as the sole criteria for grouping various types of health IT together, the draft report applies to technologies hosted on a variety of platforms, including mobile, cloud-based and installed products.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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