Michael O. Leavitt, Secretary of Health and Human Services


Washington, DC


August 1, 2006

Transcript as Delivered on New Regulations to Facilitate Adoption of Health Information Technology

Well thank you all for calling in. I'm joined here today by CMS Administrator Mark McClellan and HHS Inspector General Dan Levinson, both join me today to make this announcement and then to answer questions in a moment.

This is a big day for the announcement for the advancement of Health IT. It's a well known fact that Health Information Records help doctors provide higher quality patient care at lower cost and with less hassle.

Last month the Institute of Medicine released a report with startling statistics. More than 1.5 million Americans were injured every year by drug errors in hospitals and nursing homes and doctor offices.

On average a hospitalized patient is subject to at least one medication error per day. The IOM recommends all healthcare providers use Electronic Systems to provide prescription drugs to provide safer care at lower cost.

The President and I agree and I have been working hard to remove barriers that are keeping providers from investing in Electronic Record Systems.

These barriers include the fact that providers don't know which system to buy and they cannot afford to make a mistake. Physicians have been prohibited from getting help in investing in Health IT from those who are willing to share the bulk of the cost.

To address the first barrier, HHS has been working on finding standards that will make Electronic Health Record Systems compatible. To do so we signed a contract last year with the Certification Commission for Healthcare Information Technology, known as CCHIT, to develop the criteria and a process for certifying Health IT products to common standards.

Two weeks ago the CCHIT announced the first Outpatient Electronic Health Record products that have earned a Seal of Approval for meeting the baseline criteria for functionality and interoperability—that is the ability to talk to each other and exchange information.

Certification is vitally important to encourage the adoption of Health Information Systems. It will help purchasers of systems know that they can expect quality interoperable products.

It will reduce the risks of implementing electronic health records. This work will continue in batches.

The first batch was Outpatient or Ambulatory Electronic Health Records. More products will be announced on a quarterly basis. And next year, the Commission will certify Inpatient or Hospital EHRs. The following year it will certify systems that exchange information electronically.

And not long ago I was at Stanford University. I approached the Pathology Bench of a number of students. One of them said to me, "I am enthusiastic about Electronic Medical Records. I'm about ready to leave the university and set up a practice. I just need to know which system to buy. I can't afford to make a mistake. I can only buy one. What advice would you have?"

Well the advice now I'm able to give a student like that is to assure they buy a system that is CCHIT certified. That's a very important piece of certainty for that student and for our Health care System in total.

We want providers to eliminate the medical clipboard as we know it. We want to give them the peace of mind that comes with knowing that they're investing in Electronic Healthcare Systems that are functional and interoperable.

We also need to address the second barrier I mentioned. That means allowing those willing to invest in systems that will improve patient care to get involved. Today HHS is addressing that barrier.

This morning at a meeting of the American Health Information Community I announced that today, HHS will publish rules creating Anti-Kickback Safe Harbors and Physician Self-Referral Law Exceptions.

These new regulations will allow certain donations of Health Information Technology that may not have been permitted before. This means that hospitals, health plans, and others will be able to take on an active role in putting Electronic Health Records in the hands of physicians, and it means that physicians who are willing to use these new systems will have a better chance of getting them sooner.

To consumers of healthcare that means that we'll be another step closer to the day that we can walk into our doctor's offices—whether they are the same doctor we've seen for years or new ones—and we no longer have to recreate our entire medical history by filling out endless forms on a medical clipboard.

It means that we're a step closer to the day that we can travel the country and the world and know that our health information can travel with us.

And it means that we're closer to the day when we can rest assured that the prescriptions that we get are the ones we were intended to get by our physician and not simply a mistake because it was improperly deciphered from their handwriting.

As you may know, the House of Representatives has been working on this issue and passed a Health IT Bill that will now go to Conference with the Senate Bill. This puts us within reach of a real opportunity to further advance the work we're doing here.

Unfortunately, the House Bill contains a serious flaw of treating Health IT as if it doesn't need to be interoperable. That's like having a cell phone that can't talk with other cell phones from another network.

There are some who would welcome this and would like to promote a closed network precisely for anticompetitive reasons.

As drafted the House Bill will allow that kind of ineffective closed communication and the anticompetitive behavior that comes with it.

And I'm urging the Conferees to reexamine the Bill and to make interoperability a specific requirement. Further, I invite the Conferees to review today's Regulation and to use it as a roadmap for their own deliberations.

The HHS Regulation is the product of listening to many voices including those of the law enforcement community and balances the competing influences of rapid adoption and interoperability.

It is clear that we are on a pathway toward interoperability, and that perfect interoperability will not exist for a long time, but it is vitally important that products that are the subject of these exceptions be on that pathway.

By making the statutes consistent with HHS Regulations we'll be able to advance the Health IT initiative in a way that ensures that we are truly making progress and not memorializing future obstacles to all the benefits of information sharing.

By advancing interoperability with measures like today's rule changes and the beginning of certification of Health IT, we'll give more doctors access to Electronic Health Record Systems and this will be a big help to them to deliver on the promise of Health IT to more patients. This is higher quality healthcare at lower cost and with less hassle.

Thank you for your interest in this subject, and we'll happy to take your questions.

Last revised: September 15, 2006