A recent article in Nature highlights the Precision Medicine Initiative, launched in January 2015 and spearheaded by the National Institutes of Health. Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. This initiative will involve collection of data on genomes, electronic health records, and physiological measurements from 1 million participants. A main objective is for participants to be active partners in research.
But a major decision faced by the initiative’s working group is how much information to share with participants about disease risk, particularly genetic data. Though there is much debate in the field, the article suggests that public opinion on data sharing may be shifting toward openness.
The Precision Medicine Initiative working group will be releasing a plan soon. For details on the goals of the Precision Medicine Initiative, read the perspective by NIH Director Dr. Francis Collins in the New England Journal of Medicine.
An explosion in the collection of personal data is fostering concerns about the extent to which health information is accessed—and about the privacy and confidentiality of this information. Two recent National Public Radio stories highlight a few of the burgeoning uses of these abundant data.
In the first, an insurer uses personal data to predict who will get sick so it can identify patients at highest risk for hospital admission, or readmission, and then provide them with personal health coaches. The coordinated care given to patients by the coaches (for example, arranging a visiting nurse or streamlining appointments) has been shown to improve hospitalization rates. The insurer says it follows federal health privacy guidelines for anonymity and uses the information to better serve its members.
The second story explains that results of online health searches aren’t always confidential, and data brokers are tracking information and selling it to interested parties. The author notes that data gathered on the Web are, for the most part, unregulated. Both stories raise questions about privacy and confidentiality of health information and how to best protect it.
Pragmatic clinical trials also seek to use personal health data to answer important questions on the risks, benefits, and burdens of therapeutic interventions. In a blog post in Health Affairs, Joe Selby, executive director of the Patient-Centered Outcomes Research Institute (PCORI), underscores the need for trust, support, and active engagement of patients when involving them in health data research, even with privacy protections in place. PCORI has launched the National Patient-Centered Clinical Research Network (PCORnet) as a means of harnessing large clinical data sets to study the comparative effectiveness of treatments, and a central tenet of the network is that patients, clinicians, and healthcare systems should be actively involved in the governance of the use of health information.
Read the full articles
From NPR: Insurer Uses Personal Data To Predict Who Will Get Sick
From NPR: Online Health Searches Aren't Always Confidential
From Health Affairs: Advancing the Use of Health Data in Research With PCORnet
A new study examining public attitudes about the sharing of personal medical data through health information exchanges and distributed research networks finds a mixture of receptiveness and concerns about privacy and security. The study, conducted by researchers from the University of California, Davis and University of California, San Diego and published online in the Journal of the American Medical Informatics Association (JAMIA), reports results from a telephone survey of 800 California residents. Participants were asked for their opinions about the importance of sharing personal health data for research purposes and their feelings about related issues of security and privacy, as well as the importance of notification and permission for such sharing.
The authors found that a majority of respondents felt that sharing health data would “greatly improve” the quality of medical care and research. Further, many either somewhat or strongly agreed that the potential benefits of sharing data for research and care improvement outweighed privacy considerations (50.8%) or the right to control the use of their personal information (69.8%), although study participants also indicated that transparency regarding the purpose of any data sharing and controlling access to data remained important considerations.
However, the study’s investigators also found evidence of widespread concern over privacy and security issues, with substantial proportions of respondents reporting a belief that data sharing would have negative effects on the security (42.5%) and privacy (40.3%) of their health data. The study also explored attitudes about the need to obtain permission for sharing health data, as well as whether attitudes toward sharing data differed according to the purpose (e.g., for research vs. care) and the groups or individuals among which the data were being shared.
The authors note that while data-sharing networks are increasingly viewed as a crucial tool for enabling research and improving care on a national scale, they ultimately rely upon trust and acceptance from patients. As such, the long-term success of efforts aimed at building effective data-sharing networks may depend on accurately understanding the views of patients and accommodating their concerns.
Read the full article here:
Kim KK, Joseph JG, Ohno-Machado L. Comparison of consumers' views on electronic data sharing for healthcare and research. J Am Med Inform Assoc. 2015 Mar 30. pii: ocv014. doi: 10.1093/jamia/ocv014. [Epub ahead of print]
The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products, and procedures that improve health while protecting the privacy of research participants. The NIH news release contains highlights of the policy.
The GDS policy is an extension of and replaces the Genome-Wide Association Studies (GWAS) data sharing policy. A key tenet of the policy is the expectation that researchers obtain the informed consent of study participants for the potential future use of their de-identified data for research and for broad sharing. NIH has similar expectations for studies that involve the use of de-identified cell lines or clinical specimens.
NIH officials finalized the GDS policy after reviewing public comments on a draft released September 2013. Starting January 25, 2015, the policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data. This includes research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program. A report from members of the NIH Genomic Data Sharing policy team appears in the August 27, 2014, advance online issue of Nature Genetics.