Sunday, December 21, 2008

A Unique Patient Identifier could be Beneficial, But At What Price?

Linda was in constant pain so she went to the hospital emergency room where she was diagnosed with a severe stomach virus. After two weeks the pain got worse so she went to a clinic where she saw a gastroenterologist who ordered a CT scan which showed a large mass on her pancreas. Linda had a biopsy and was diagnosed with acute pancreatitis, given medication, and instructed to follow up in six months. The results of this incident were recorded in an electronic record. Six months later, Linda had changed jobs and relocated to another State. She tried to access her record, but discovered that the clinic had merged with a large hospital and they could not find the record. Her new doctors were unable to compare her current CT scan with the initial test, thus compromising their ability to give her the best follow-up care.

There is much talk about the benefits of electronic health records enabling doctors to have full information on a patient at the point of care. However, considering the mobility of the American population, there is a missing link, the absence of a unique patient identifier for every individual that enables the healthcare provider to look up data on that patient whenever and wherever they seek care. By their very nature, electronic records demand that individuals be uniquely identified if the processes of enrollment and authentication are done right.

Rand Research in 2008 conducted a study that concluded that a unique patient identification number system is necessary to reduce medical errors, protect privacy and simplify the use of electronic records. The idea is that associating data such as a sequence of numbers and letters with a particular human enables authentication of the individual and their health information that is resident in digital format. Current systems that match individuals with their information using attributes such as name, birth date, address, zip code, gender, medical record numbers, and all or part of the social security number are not as efficient since some of these factors such as name or address/zip code can change over time.

Unique Patient Identification is not a new idea. In 1996 HIPAA legislation included a provision that asked that the Department of Health and Human Services issue unique patient ID numbers for all Americans’ medical information. The United States Congress reversed that provision after privacy advocates protested that such a system would violate the individual’s privacy protections and bring too much government interference into the health care system. With a massive database of over 300 million individuals with individual patient identifications, privacy issues loom large. Furthermore the Rand Study estimates that building that database could cost as much as $11 billion.

In the United Kingdom and in other European countries national identity smart cards have been tried with some level of success. It would be highly beneficial to individuals and the American healthcare system that an electronic record that includes an individual’s comprehensive health information could be accessed with a unique 9 or 10 digit ID. This is a task for Mr. Daschle’s Federal Health Board to consider as the new administration establishes its short and long term objectives.

Wednesday, December 3, 2008

Personalized Medicine, the Next Frontier

When an individual patient visits his or her doctor with a problem, traditional clinical diagnosis is made and treatment is administered based on the patient’s symptoms, medical and family history and results of lab tests.

In the e-health world of the 21st century, personalized medicine, a new approach to treatment and analysis of patients’ health issues, promises to revolutionize that process. Personalized medicine looks not only at an individual’s symptoms, labs and medical history but at the individual’s unique clinical genetic and genomic markers to determine a treatment program. Because these factors differ for each human being, the disease they carry and how they will respond to treatment will differ as well. Taking this to another level, personalized medicine enables doctors to make accurate predictions and assumptions not only about an existing condition but to make predictions about a person’s potential to develop a disease. This will enable clinicians to treat patients proactively rather than reactively resulting in a better outcome.

Personalized medicine is gathering momentum as evidenced by the significant attendance and enthusiastic involvement of the participants at the recent conference sponsored by Harvard Medical School and the Center for Genetics and Genomics at Partners Healthcare. Although there was general agreement that personalized medicine is now an accepted way to look at the patient, there are also enormous barriers to its widespread use, including:

1. Economic factors such as who will receive and who will pay for genetic testing.

2. Issues regarding who will be responsible for building the infrastructure needed to support widespread deployment,

3. Concerns about how we amass, use, and protect the vast knowledge base that results from genetic tests.

4. Legal questions regarding who owns the genetic test data - the patient, the physician, the institution - and whether or not that information can be used for additional research.

5. Unresolved issues regarding standards upon which to build a platform for using personalized medicine

6. Discussions about how to structure collaborations amongst all the stakeholders (patients, physicians and scientists) so that personalized medicine advances are translated ultimately into better patient care.

E-patients must be part of the conversation that determines where we are going with personalized medicine because personalized medicine uses genomics to focus not only on disease identification tied to a specific combination of genes in an individual, but also on disease prevention and wellness in which everyone has a high stake.