FDA Releases Report on Health IT Oversight

On April 3, 2014, the Food and Drug Administration (“FDA”), in collaboration with the Office of the National Coordinator for Health Information Technology (“ONC”) and the Federal Communications Commission (“FCC”), released a congressionally mandated report which proposes to clarify oversight of health information technology (“health IT”) based on a product’s function and the potential risk to patients who use it. The full draft report can be viewed here.

Similar to the FDA’s September 2013 guidance on how it would regulate mobile medical apps, this report proposes a strategy based on the premise that risk and corresponding controls should focus on health IT functionality– not the platform(s) on which such functionality resides.  As such, the FDA has identified three categories of health IT: (1) administrative health IT functions (2) health management health IT functions, and (3) medical device health IT functions.  The following table provides examples of the three categories and describes the FDA’s regulatory approach for each:

 

Health IT Category Examples (includes but not limited to) Level of Oversight
Administrative functionality Billing and claims processing, practice and inventory management,  scheduling, general purpose communications, determination of health benefit eligibility, population health management, reporting of communicable diseases to public health agency, quality measure reporting No additional oversight necessary
Health management functionality (sometimes referred to as “clinical software”) Health information and data exchange, data capture and encounter documentation, electronic access to clinical results, most clinical decision support, medication management, electronic communication and coordination, provider order entry, knowledge management, patient identification and matching Not focus of FDA oversight given proposed risk-based framework for health management  health IT
Medical device functionality Computer aided detection/diagnostic software, remote display or notification of real-time alarms from bedside monitors, robotic surgical planning and control Focus of FDA oversight

 

A significant portion of the FDA’s report focuses on the proposed framework for health management health IT functionalities.  Instead of recommending a new or additional area of FDA oversight, the report recommends a limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities.  Four key priority areas for health management health IT include: (1) promote the use of quality management principles (2) identify, develop, and adopt standards and best practices (3) leverage conformity assessment tools and (4) create an environment of learning and continual improvement.

The framework also  includes a recommendation for ONC to create a public-private Health IT Safety Center, in collaboration with FDA, FCC, and Agency for Healthcare Research and Quality (“AHRQ”) and other health IT stakeholders. This Center would work on best practices and provide a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.

What do you think about the FDA’s health IT report?  The FDA is seeking public input on a number of specific questions related to the report’s recommendations– the report is open to public input/comment for 90 days.  For more information about the FDA report or health IT regulatory issues, please contact Jefferson Lin or David Schoolcraft.

 

 

Proposal Would Extend EHR Donation Rules

The U.S. Department of Health and Human Services (HHS) has released proposed rules to amend the electronic health record (EHR) donation exception and safe harbor under the Stark Law and Anti-Kickback Statute.  The exception and safe harbor permit certain entities to share costs associated with EHR-related items and services with other entities.   Under the regulations, the receiving party must pay at least 15 percent of the donor’s cost for the items and services.

The current language of the regulations has a “sunset” provision that requires a donor to transfer EHR items and services on or before December 31, 2013.  Under the proposed rules, HHS would extend the sunset provision three years to December 31, 2016.

Without the rule change, existing donation arrangements would have to convert to a “fair market value” model for shared services and technology.  The existing sunset provisions also provide a significant barrier to the development of new arrangements. 

The rules also include the following proposed revisions to the regulations: (1) changes to the requirements for when EHR software is deemed “interoperable, (2) removal of the requirement related to electronic prescribing capability, and (3) limits on the types of entities that are allowed to make EHR donations.

HHS also seeks suggestions on how to achieve the following goals under the exception and safe harbor: (1) preventing the misuse of donated EHR technology in a way that results in data and referral lock-in, and (2) encouraging the free exchange of data created by donated software.

You can view the proposed rule for the Anti-Kickback Statute here and the proposed rule for the Stark Law here.

HHS will accept comments to the proposed rules until June 10, 2013.

If you have any questions about donating EHR technology under the Anti-Kickback Statute and Stark Law, please contact David Schoolcraft or Casey Moriarty.

OIG Approves Electronic Interface Arrangement

In a recent advisory opinion, the Office of Inspector General DHHS (“OIG”) approved an arrangement under which free access to an electronic computer interface is provided by a hospital to local physicians.  The opinion provides an important contemporary analog to earlier guidance published by the OIG as part of the preamble to the Federal anti-kickback statute safe harbor regulations (see 56 Fed. Reg. 35952, 35978, July 29, 1991).   At the same time, the OIG reinforced its long-standing position that in order for such arrangements to pass muster under the Federal anti-kickback statute, the parties must validate that the technology is limited to facilitating hospital-physician communications, and that it will not have independent value to the physicians. 

Please contact David Schoolcraft  (dschoolcraft@omwlaw.com or 206.447.7000) you have any questions about the scope and applicability of this OIG advisory opinion.

MIT Enterprise Forum Focus on Health IT – March 14th

Interested in Health Information Technology and live in the Pacific Northwest?  Then you should attend the MIT Enterprise Forum on Health IT.

Wed, 03/14/2012 – 5:00pm – 8:30pm

MOHAI

2700 24th Avenue East
Seattle, WA
To register click here.

Ogden Murphy Wallace is a proud sponsor of the event.

Health IT is transforming our healthcare system. Healthcare reform, industry consolidation, and demographic changes have spurred a significant increase in the U.S. healthcare industry’s use of technology to improve health and enhance the patient experience while trying to help control the ever-increasing cost of care. New players are emerging and cloud computing, social media, and mobile technology solutions targeting patients and healthcare providers are creating new opportunities.

Join us for our March 14 MIT Enterprise Forum and discover how NW technology entrepreneurs can identify these opportunities and succeed in the health IT market. Our panel of industry thought-leaders moderated by Rob Coppedge, Vice President of Business and Corporate Development at Cambia Health Solutions, includes:

  • Sailesh Chutani, CEO, Mobisante
  • Peter Gelpi, CEO, Clarity Health
  • Luis Machuca, President & CEO, Kryptiq Corporation
  • Gwen O’Keefe, MD, Chief Medical Informatics Officer, Group Health

Our panel will provide an overview of major health IT trends, the new opportunities technology presents for both patients and healthcare providers, as well as explain how this may enable change in the traditional healthcare industry cost structure. Most importantly, our speakers will identify business opportunities and what regulatory restrictions such as HIPAA really mean for the NW technology entrepreneur community.

Audience Takeaways

During this event, you will learn:

  • How the health IT market has changed in the wake of healthcare reform and government investment incentives
  • What different types of care and cost models might look like, and what opportunities those present for entrepreneurs
  • Potential sources of funding for innovative health IT technologies
  • Approaches entrepreneurs can take to handle barriers presented by government regulations such as HIPAA