Robert Kolodner MD, is the National Coordinator of the Office of the National Coordinator for Health Information Technology. He's the newest and second coordinator charged with the responsibility to facilitate the adoption of health care IT.

Kolodner started his presentation with some sobering patient safety data:

  • Medical errors are killing more people per year, in the U.S., than breast cancer, AIDS, or motor vehicle accidents.
  • The lack of immediate access to patient
    health care information is the source of
    one-fifth of these errors.
  • Health care is expected to account for $1 of every $5 spent in the United States.
  • Cost of health insurance will rise 6.4% annually.
  • Spending on health care will continue to outpace the entire economy - $4 Trillion total in 2016.

He noted a variety of factors contributing to changes in health care delivery in the US.

While Kolodner admitted that his presentation was not prepared for our group, he did seem to present his overview of the government's efforts in promoting health care IT with an increased awareness of the important role played by medical devices. He noted that medical devices is not on the list – something that he will have to address. He did mention standards and interoperability of health information and that this must extend to medical devices soon.

We are all potential patients – and if not us, than family members, friends, neighbors. As we go forward promoting medical device interoperability, make it personal.

He noted that we have lots of data locked up in lots of devices, device systems, information systems.

The 4 cornerstones to reach HHS Secretary Leavitt’s goal of improved health care: the value driven health care agenda

  1. Connecting the system
  2. Measure and publish quality
  3. Measure and publish price
  4. Create positive incentives

Change occurs not in a straight line, but one must look for the tipping points. The federal governments points of leverage include laws, procurement, conditions of doing business, reimbursement and collaborations. All levers that are being vigorously pursued.

The American Health Information Community – AHIC “the Community” is a federal advisory committee chaired by Leavitt. The committee has 17 members and provides input and recommendations to HHS. Detailed work is performed in work groups and brought back to committee. To date, 7 workgroups have been established, with over 50 meetings. There are no workgroup on connectivity or systems engineering - yet. The workgroups create use cases that go to standards panel who selects/endorses standards and supports certification.

He showed past current and potential use cases. Potential use cases for 2008 include: Remote Monitoring of Vital Signs & Labs, Referrals and Transfer of Care, Remote Consultation, and others. In parallel Kolodner is focused on governence, policy, technology – interop: standards harmonization by HITSP, and adoption.


Kolodner “Personal health record may be the disruptive tech of the future”
What about global perspective (“super commuters”) ? Until we move forward in the US, we can’t move beyond borders. He has been in discussions with Euro, China and Australia.

Contrast between IOM adjetives around quality of care and Kolodner’s longitudinal slide – what about adoption at the front line of care? Moving in steady thoughtful fashion. Safe Harbor is one move that has gained some traction. They’re looking at other things in a discovery and learning process.

How do you know it will all work? Software isn’t perfect, and we’re adding a level of complexity and combining multiple systems – what steps are/shoud be taken to realize the same level of confidence in our software as we have in devices? The device area has some real challenges that differe the HER. EHRs have been moving data around reliably for some time. Linking devices entails more interoperability rather than just passing data back and forth. There will be errors along the way, and we’ll need a patient safety role to pick up safety issues as they occur. When software is controlling devices,.. Kolodner really didn’t have an answer. He recognized the need. He knows our execution here will not be perfect – need risk analysis to determine benefit of new risk over patients that are currently killed.

Who are the certifying agencies for medical device interoperability? CCHIT is not an exclusive body with published criteria that could be used by another body.

Nat Sims mentioned a medical device integration project they’re doing among ambulatory clinics and practitioners.

Made distinction between data in devices and data in software. What about work on the issues regarding moving data between devices and HIT? There are not any policies in place for this, especially when considering safety inter locks rather than just moving data. This is an area that will require work in the future.

He noted that he received a number of very challenging questions.

Comment on the role of data generated by medical devices in HIT, and, how far does your mandate extend down to sources of clinical data?

Pictured right is Insup Lee, Robert Kolodner, and Julian Goldman.