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October 22, 2008 Readers Write 2 Comments

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Personal Health Records are Durable Medical Equipment
By Manfred Sternberg, J.D.
Presiding Officer, Board of Directors, Texas Health Services Authority

There is little debate that knowledge and information have always been among a physician’s best clinical tools. Consistent with this fact, information technology (IT) should be viewed by the healthcare industry as a medical device. With the advent of evidence-based medicine coupled with advances of IT, we are in many ways on the brink of a golden age of medicine.

In the relatively near future, information supporting evidence based medicine will translate from bench to bedside at speeds never before witnessed. We will have more accurate information to treat health issues more appropriately, based on the data, than ever before.

Admittedly, IT is in many ways a crude medical device, but that is today. Many of the now traditional medical devices that were introduced into the healthcare market throughout history started off as crude devices; think about surgical tools.

ms Like other medical devices, this device is certain to evolve with use, experience, and continued development and innovation. Many predict that the use of this IT device by healthcare professionals will become the standard of practice, like scrubbing in before surgery. The legitimate debate generally centers on how and when.

As with other changes in medicine, the adoption of this new tool will be an evolution. It will not happen by just flipping a switch at the end of any given year, it will evolve. Consumers and their physicians must participate in this evolution for it to ultimately be successful. The consumer’s best platform to effectively and economically engage with the industry is a standardized personal heath record (PHR).

What is a PHR?

A PHR is an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual.

PHRs may also include information that is entered by consumers themselves, as well as data from other sources such as pharmacies, labs, and care providers. PHRs enable individual patients and their designated caregivers to view and manage health information and play a greater role in their own health care. PHRs are distinct from electronic health records, which providers use to store and manage detailed clinical information.

The Benefits of using a PHR

There is consensus among stakeholders that the widespread adoption of health information technology will lead to safer, more effective healthcare. Experts believe adoption of technology will reduce preventable errors, such as medication errors, increase compliance with recommended treatments, improve treatment for people with chronic disease, and contribute to lower health care costs.

Ultimately, this new tool will allow physicians to benefit from improved information about each patient, and consumers and doctors can share that information to make the best decisions concerning their healthcare. Better data (e.g. timely, personalized clinical and billing data) provides better results whether in the hands of a physician, patient, health coach, or measurement program Additionally, care coordination from a process management perspective is critical to improved results

Consumer Empowerment

Consumers have great interest in the subject of healthcare. It is the most searched subject on the Internet, yet the long predicted wave of consumer empowerment in healthcare has yet to arrive.

Consumers, as well as the business community, are generally unaware of the healthcare cost and quality issues and interoperability issues. Nor do they recognize that they have a new, long anticipated, role as purchasers seeking value in the healthcare delivery system. They tolerate the existence of numerous inefficiencies and cost in the healthcare sector far more than in any other market, because of and in spite of its relative importance and their inability to judge value.

Today, the consumer is unable to identify value without information on cost and quality. Quality cannot be identified without measurement and it cannot be compared without standardization.

Since the mass adoption of the Internet, the benefits of IT have embedded themselves into society as one of the most powerful tools that consumers have ever had. Endless information is now available in everyone’s home. Society has embraced this new found consumer tool, but comprehensive personal clinical information has not digitally made its way into the consumer’s hands. To some degree it is not readily recommended or available, yet.

How does a consumer get educated about their new role in their own health and their interaction with the healthcare delivery system? Who do they trust to guide them? Consumers trust their physicians far more than any other group in the Healthcare system. They certainly value their doctor’s advice, even if they don’t follow it all of the time.

Today, the consumer is effectively, unwittingly waiting on their physicians to recommend this new medical device for their health. Therefore, engagement of the physician is the key to fostering consumer empowerment.

What is Durable Medical Equipment (DME)?

There is no single authority, such as a federal agency that confers the official status of DME on any device or product. A fairly comprehensive definition of Durable Medical Equipment as contained in a Texas Group Policy is as follows:

Durable Medical Equipment is defined as being equipment that:

  • can withstand repeated use; and
  • is primarily and customarily used to serve a medical purpose; and
  • is generally not useful to a person who is not sick or injured, or used by other family members; and
  • is appropriate for home use; and
  • improves bodily function caused by sickness or injury, or further prevents deterioration of the medical condition; and
  • is prescribed by a physician.

A consumer’s PHR fits the definition as follows:

Durable Medical Equipment means

equipment : Noun. An instrumentality needed for an undertaking or to perform a service.


  • can withstand repeated use. A PHR easily withstands repeated use.
  • is primarily and customarily used to serve a medical purpose. A PHR contains a consumer’s relevant medical information so many medical decisions can be made based on the contents of the record.
  • is generally not useful to a person who is not sick or injured, or used by other family members. A PHR is not useful to anyone in the consumer’s family but the consumer and only the consumer can use it to track and support her health or coordinate her care when she is ill
  • is appropriate for home use. A PHR is appropriate for home use or anyplace a consumer has a connection to the Internet.
  • improves bodily function caused by sickness or injury, or further prevents deterioration of the medical condition. According to the trade association that represents insurance plans and the executives of most plans, there is consensus among stakeholders that the widespread adoption of health information technology will lead to safer, more effective health care. Experts believe adoption of technology will reduce preventable errors, such as medication errors, increase compliance with recommended treatments, improve treatment for people with chronic disease, and contribute to lower health care costs.

and is prescribed by a Physician; Can physicians professionally make this recommendation to their patients? It depends on whether they can professionally agree with the statement that “a PHR is a medical device that in certain cases can benefit their patient’s ongoing health or illness.”

If physicians prescribe a PHR for their patients, and the Payers collectively agree to pay the costs, the standard of practice in a community will change. Physicians will create a new business model in order to pay for their EMR system, and the power of a new medical device can be leveraged for the benefit of the consumer.

The PHR information must be stored in a secure way with patient privacy a cornerstone of the repository. Physicians must play a role in the central repository of this clinical information in terms of governance and oversight with appropriate financial compensation for their participation.

If every physician in Harris County, Texas prescribes a PHR for every patient that could benefit from such a device, it will be a catalyst for the creation of a clinical information database that would be owned and controlled by doctors and their patients.

The opportunity for today’s leaders is to take steps to enable our community to appropriately leverage the power and value of the data. To be sure, this is not as much a technology problem as it is a sociology issue. The first step is for the Industry is to acknowledge IT for what it is, a medical device.

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Currently there are "2 comments" on this Article:

  1. Are PHR vendors treating these products as Medical Devices with respect to FDA compliance? This is certainly an area of interest to the FDA.

  2. No PHR vendor is treating PHRs as Medical Devices that I know of as that would require a longer term vision than making their number next quarter. (Full disclosure, I am not in the PHR business.) My intent was not to get the FDA involved in regulation by using the words”medical device”, instead my intent was to use the terms as descriptive, so that the industry could maybe look at this product in a different way. Look at how the payers are pushing PHRs, because they recognize these “tools” have a clinincal and financial benefit, the public and the docs just dont want these data repositories from the Payers, probably just a healthy distrust. Good idea, just the wrong party offering the device. Call it a tool, medical device or DME, same result, just dont get the FDA involved, we have enough problems.

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