Personal health records and clinical trials
Can personal health records (PHRs) revolutionize the clinical trial industry? In our opinion: Yes. We’re interested in what you think, as well.
To foster a discussion to solicit your opinion, find below a primer on PHR and what the public and private sector are doing to promote PHRs.
What are PHRs?
PHR is a patient-controlled document of his or her health information in a format of his or her choice. (A medical health record, by contrast, is patient health information controlled by a physician, healthcare institution or health insurance company.) Information documented in a PHR can be as limited as emergency health information to facilitate emergent care or as broad as all provider visits, diagnostic records, prescriptions, and health insurance information. Storage formats can range from a local computer hard drive, portable hard drive, or internet-based subscription service.
Public sector PHR activity
Medicare (Centers for Medicare & Medicaid Services), since 2006, has undertaken several pilot programs to encourage the use of PHRs. For more about Medicare pilots, click here. A number of policy recommendations have been made by the National Coordinator of Health Information Technology.
Certification Commission for Health Information Technology (CCHIT) has assembled a special PHR Advisory Task Force and created an associated workgroup in order to draft a set of certification criteria for PHRs. The certification criteria, which are scheduled for release by 2010, will place an emphasis on industry privacy safeguards while also addressing security and interoperability issues. For more information, click here.
A number of states have introduced legislation to govern the usage of PHRs. For a survey of state-level legislation, see the National Conference of State Legislatures tracking by clicking here.
Private sector PHR activity
A list of players in the PHRs:
- CapMed.com
- Microsoft HealthVault
- Caregiver Alliance Web Services
- MiVia
- CEND-PHR
- MyGroupHealth (Group Health Cooperative)
- Collaborative Family Health Record
- MyHealtheVet (U.S. Department of Veterans Affairs)
- Dossia
- MyHIN
- FollowMe
- MyMedicalRecords.com
- Google Health
- Myphr.com
- HealthAtoZ
- Patient Gateway (Partners HealthCare)
- iHealthRecord.com
- PatientSite (Beth Israel Deaconess Medical Center)
- LifeOnKey
- RecordsForLiving.com
- Med Alert
- e-Healthkey
- Revolution Health Group
- MedCommons
- VitalChart
While not meant to be exhaustive, the list above suggests that policy announcements have encouraged a proliferation of private sector offerings in the PHR space. For a more exhaustive list, visit myPHR. In addition, several non-profit organizations have initiated studies to evaluate standards to optimize interoperability, security and data modification (see Robert Wood Johnson Foundation, PDF).
Opportunity for clinical trials
The “low-handing fruit” for science and clinical research, in our opinion, lies in the intersection of PHRs and these core areas:
- Analysis of diagnostic data for patient identification for clinical trial recruitment
- Self-identification for clinical trial recruitment
- Analysis of historical records for hypothesis creation
Interested in your opinions…
Electronic Medical Records (EMR) also play an important role in clinical trials from the providers perspective. As Chris Thorman writes in his guest post on Health Commentary (http://healthcommentary.org/?page_id=2448), providers can dramatically increase revenue by implementing an EMR to enable participation in clinical trials:
“Holston Medical Group (HMG) in Kingsport, TN, began using an EHR in 1996, the company began participating in clinical trials using the data from their EHR. HMG’s income from clinical research went from $86,700 in the first year (1996) to $1.9 million in 2004, with estimated 2005 revenues of $2.5 million.”
Clinical trial expert
30 Mar 10 at 7:51 pm
Great post.
Another opportunity with PHRs in clinical trials is patient-authorized data sharing from trusted 3rd parties.
Today data in clinical trials is sourced from the investigator (ex clinical evaluations), study-contracted 3rd parties (ex central labs), and the patient (ex self-report/PRO). Often there is other data “around” the patient that may be of value — labs, imaging studies, other physician evaluations. Many are difficult to obtain as they are captured in disparate electronic health records/systems.
Where a patient has access to and control over their health information, they can then authorize and share that information with clinical trial databases (a connection recently announced by Omnicomm EDC and MSFT HealthVault as an example).
Craig
26 Apr 10 at 10:12 am
Craig –
Thank you for your insightful comment.
The opportunity is certainly real for innovation in an intermediate layer of software that can interface with variant sources of health information. The MSFT HealthVault strategy of providing a software development kit to third-party application developers and device manufacturers seems quite promising and, moreover, a validated approach given Apple’s and Microsoft’s own experience (e.g., iPhone apps and Microsoft Windows drivers). The network effect creates immense value.
We at TrialDox find such an approach for clinical trial operations promising, as well. Consider the efficiencies attainable if clinical trial sites, investigators and research sponsors could interface with a common platform that can interface with variant sources of clinical trial documentation. The network effect of a common platform is exciting.
We’d be happy to discuss further with you and collaborate with you.
The TrialDox Team
admin
26 Apr 10 at 8:10 pm
To TrialDox Team.
You will be thrilled to know that your vision is indeed implemented.
We at LifeOnKey, together with Target Health, have announced today our new integrated EHR, PHR and Registry with Target eCRO product for Clinical Trials and Post Marketing Surveillance.
Please go to http://www.lifeonkey.com to the Company>News PR from Today. Thanks!!!
Linda
19 Jul 10 at 4:20 pm
Linda –
Congratulations! Very exciting news to hear about your new solution. All the best to you, your company and partners in driving adoption of your solution.
Keep us apprised of your progress!
The TrialDox Team
admin
19 Jul 10 at 4:46 pm