Giving patients granular control of personal health information: Using an ethics ‘Points to Consider’ to inform informatics system designers

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion

Managing Medicaid Pharmacy Benefits: Current Issues and Options

Examines issues and considerations for state reforms of Medicaid prescription drug reimbursement, pharmacy management, and cost sharing and other best practices for realizing savings

What You Need to Know about Bar-Code Medication Administration

Medication errors are the most common type of preventable error. Bar-code medication administration (BCMA) technology was designed to reduce medication administration errors. Poor system design, implementation and workarounds remain a cause of errors. This paper reviews the literature on BCMA, identifies a gap in the findings and identifies three evidence based practices that could be used to improve system implementation and reduce error. The literature review identified that Bar-code medication administration and system workarounds are well documented and affect patient safety. Based on the critical analysis of 10 studies, we identified gaps in the standardization of BCMA planning, implementation, and sustainability. The themes that emerged from the literature were poor BCMA design and implementation that resulted in workarounds.The three evidence based strategies proposed to address this gap are, evidence based standardization in planning and implementation, the identification and elimination of workarounds and hard wiring. An evidence based checklist evaluates compliance with standard procedures. The LEAN model of Jodoka is used to assure adaptation of the machine to human workflow. Direct observation provides valuable workflow assessment. An effective BCMA implementation involves careful system design, identification of workflow issues which cause workarounds, and adapting the machine to nursing needs

Prototype of running clinical trials in an untrustworthy environment using blockchain.

Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials

Big Data and the Internet of Things

Advances in sensing and computing capabilities are making it possible to embed increasing computing power in small devices. This has enabled the sensing devices not just to passively capture data at very high resolution but also to take sophisticated actions in response. Combined with advances in communication, this is resulting in an ecosystem of highly interconnected devices referred to as the Internet of Things - IoT. In conjunction, the advances in machine learning have allowed building models on this ever increasing amounts of data. Consequently, devices all the way from heavy assets such as aircraft engines to wearables such as health monitors can all now not only generate massive amounts of data but can draw back on aggregate analytics to "improve" their performance over time. Big data analytics has been identified as a key enabler for the IoT. In this chapter, we discuss various avenues of the IoT where big data analytics either is already making a significant impact or is on the cusp of doing so. We also discuss social implications and areas of concern.Comment: 33 pages. draft of upcoming book chapter in Japkowicz and Stefanowski (eds.) Big Data Analysis: New algorithms for a new society, Springer Series on Studies in Big Data, to appea

FEDERAL RESEARCH: Additional Actions Needed to Improve Public Access to Research Results

Why GAO Did This Study --Research and development helps catalyze breakthroughs that improve the overall health and wellbeing of our society. Federal research and development expenditures averaged about $135 billion annually for fiscal years 2015 to 2017. According to OSTP, providing free public access to federally funded research results can improve both the impact and accountability of this important federal investment. In February 2013, OSTP directed federal agencies with more than$100 million in annual research and development expenditures to develop a plan to support increased public access to the results of federally funded research. GAO was asked to examine public access to federally funded research results. This report examines the extent of agencies’ (1) progress implementing plans to increase public access to federally funded research results and (2) coordination on public access plan implementation. GAO administered a questionnaire to 19 federal agencies selected based on annual research and development expenditure amounts, among other criteria; reviewed agency documents; and interviewed officials from 11 agencies, OSTP, and 21 stakeholder organizations. What GAO Recommends-- GAO is making 37 recommendations to 16 agencies to promote full and effective implementation of agency public access plans. For example, GAO recommends that OSTP and 5 agencies leading a public access interagency group take steps to fully implement selected leading collaboration practices. Of the 16 agencies, 15 agreed with GAO’s recommendations while 1 (OSTP) disagreed. GAO continues to believe the recommendation to OSTP is warranted. What GAO Found --The 19 agencies that GAO reviewed have made progress implementing their plans to increase public access to federally funded research results (publications and data), as called for in a 2013 Office of Science and Technology Policy (OSTP) memorandum. However, some agencies have not fully implemented some aspects of their plans, in particular those related to data access and mechanisms to ensure researchers comply with public access requirements

FEDERAL RESEARCH: Additional Actions Needed to Improve Public Access to Research Results

Why GAO Did This Study --Research and development helps catalyze breakthroughs that improve the overall health and wellbeing of our society. Federal research and development expenditures averaged about $135 billion annually for fiscal years 2015 to 2017. According to OSTP, providing free public access to federally funded research results can improve both the impact and accountability of this important federal investment. In February 2013, OSTP directed federal agencies with more than$100 million in annual research and development expenditures to develop a plan to support increased public access to the results of federally funded research. GAO was asked to examine public access to federally funded research results. This report examines the extent of agencies’ (1) progress implementing plans to increase public access to federally funded research results and (2) coordination on public access plan implementation. GAO administered a questionnaire to 19 federal agencies selected based on annual research and development expenditure amounts, among other criteria; reviewed agency documents; and interviewed officials from 11 agencies, OSTP, and 21 stakeholder organizations. What GAO Recommends-- GAO is making 37 recommendations to 16 agencies to promote full and effective implementation of agency public access plans. For example, GAO recommends that OSTP and 5 agencies leading a public access interagency group take steps to fully implement selected leading collaboration practices. Of the 16 agencies, 15 agreed with GAO’s recommendations while 1 (OSTP) disagreed. GAO continues to believe the recommendation to OSTP is warranted. What GAO Found --The 19 agencies that GAO reviewed have made progress implementing their plans to increase public access to federally funded research results (publications and data), as called for in a 2013 Office of Science and Technology Policy (OSTP) memorandum. However, some agencies have not fully implemented some aspects of their plans, in particular those related to data access and mechanisms to ensure researchers comply with public access requirements