The Use and Misuse of Biomedical Data: Is Bigger Really Better?

@article{Hoffman2013TheUA,
  title={The Use and Misuse of Biomedical Data: Is Bigger Really Better?},
  author={Sharona Hoffman and Andy Podgurski},
  journal={American Journal of Law \& Medicine},
  year={2013},
  volume={39},
  pages={497 - 538}
}
Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data? This paper makes an original contribution to the… 

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References

SHOWING 1-10 OF 171 REFERENCES

Big Bad Data: Law, Public Health, and Biomedical Databases

  • S. HoffmanAndy Podgurski
  • Medicine, Political Science
    The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
  • 2013
Several regulatory and other interventions are outlined by this paper to address data analysis difficulties that could result in invalid conclusions and unsound public health policies.

Mining electronic health records: towards better research applications and clinical care

The potential for furthering medical research and clinical care using EHR data and the challenges that must be overcome before this is a reality are considered.

Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems

It is argued that the advantages of EHR systems will outweigh their risks only if these systems are developed and maintained with rigorous adherence to best software engineering and medical informatics practices, and regulatory intervention is needed to ensure that these goals are achieved.

Learning from our GWAS mistakes: from experimental design to scientific method

In an era of large-scale biological research, questions are asked about the role of statistical analyses in advancing coherent theories of diseases and their mechanisms and for renewed appreciation of falsifiable hypotheses so that the authors can learn more from their best mistakes.

Helping Doctors and Patients Make Sense of Health Statistics

Evidence is provided that statistical illiteracy is common to patients, journalists, and physicians and that information pamphlets, Web sites, leaflets distributed by the pharmaceutical industry, and even medical journals often report evidence in nontransparent forms that suggest big benefits of featured interventions and small harms.

Analysis of Data Errors in Clinical Research Databases

Analysis of data from several clinical research databases at a single academic medical center to assess frequency, distribution and features of data entry errors found many errors were non-random, organized in special and cognitive clusters, and some could potentially affect the interpretation of the study results.

Minimizing bias due to confounding by indication in comparative effectiveness research: the importance of restriction.

The large number of available antihypertensive agents, many used as first-line treatments, has made it possible to conduct observational studies of comparative effectiveness, and it is difficult to design a convincing observational study that compares oral agents with insulin for outcomes that are related to disease duration or severity.

Patient Data: Property, Privacy & the Public Interest

  • M. Rodwin
  • Medicine
    American Journal of Law & Medicine
  • 2010
This new technology requires that the ambiguous property interests in patient data are clarified, and how the law defines ownership of patient data will shape whether its benefits can be developed and also affects patient confidentiality.

The eMERGE Network: A consortium of biorepositories linked to electronic medical records data for conducting genomic studies

By combining advanced clinical informatics, genome science, and community consultation, eMERGE represents a first step in the development of data-driven approaches to incorporate genomic information into routine healthcare delivery.

Measuring Statutory Law and Regulations for Empirical Research

Effectively studying the relationship between law and population health requires (1) variation in both the law and health outcomes being studied, preferably over space as well as time, and (2) valid
...