AMIA calls for tighter coordination of data privacy rules

The American Medical Informatics Association is asking the Trump administration to take a close look at both HIPAA and the Common Rule to see how they might be updated or harmonized for a new era of privacy policy.

Specifically, the AMIA wants a more integrated approach to how policies aimed at both the "health sector" and "consumer sector" are defined.

The full Healthcare IT News article can be viewed at this link.  

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that need additional evaluation either at the time of initial approval or later, once the drug has been marketed. These issues are evaluated through the conduct of additional post-marketing studies.

Today we’re announcing our FY 2017 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. This report provides an update on how we’re doing at holding companies accountable for completing these important studies on time to ensure that our understanding of a drug’s safety and efficacy keeps pace with its use in all relevant populations once a product is approved. We’re committed to ensuring that PMRs and PMCs are conducted and reported as required, and to providing transparent access to the progress of these studies for the public.

The full statement can be viewed at this link.  

The 2017 report can be downloaded below.  

Primary care physicians’ attitudes to the adoption of electronic medical records: a systematic review and evidence synthesis using the clinical adoption framework

Recent decades have seen rapid growth in the implementation of Electronic Medical Records (EMRs) in healthcare settings in both developed regions as well as low and middle income countries. Yet despite substantial investment, the implementation of EMRs in some primary care systems has lagged behind other settings, with piecemeal adoption of EMR functionality by primary care physicians (PCPs) themselves. We aimed to review and synthesise international literature on the attitudes of PCPs to EMR adoption using the Clinical Adoption (CA) Framework. MEDLINE, PsycINFO, and EMBASE were searched from 1st January 1996 to 1st August 2017 for studies investigating PCP attitudes towards EMR adoption. Papers were screened by two independent reviewers, and eligible studies selected for further assessment. Findings were categorised against the CA Framework and the quality of studies assessed against one of three appropriate tools. Out of 2263 potential articles, 33 were included, based in North and South America, Europe, Middle East and Hong Kong. Concerns about the accessibility, reliability and EMR utility exerted an adverse influence on PCPs’ attitudes to adoption. However many were positive about their potential to improve clinical productivity, patient safety and care quality. Younger, computer-literate PCPs, based in large/multi-group practices, were more likely to be positively inclined to EMR use than older physicians, less-skilled in technology use, based in solo practices. Adequate training, policies and procedures favourably impacted on PCPs’ views on EMR implementation. Financial factors were common system level influencers shaping EMR adoption, from start-up costs to the resources required by ongoing use. By using the CA Framework to synthesise the evidence, we identified a linked series of factors influencing PCPs attitudes to EMR adoption. Findings underline the need to involve end-users in future implementation programmes from the outset, to avoid the development of an EMR which is neither feasible nor acceptable for use in practice.

The full article can be downloaded below.  

Slides from presentation by Stephen Konya, Senior Innovation Strategist, Office of the National Coordinator (ONC) at eHI's 10/31/18 Prior Authorization workshop.

Presentation includes what ONC is doing with prior authorization:

• The ONC Payer + Provider (P2) FHIR Taskforce​

• 21st Century Cures Act – Report on Reduction in Clinician Burden​

• ONC is working closely with CMS to analyze PA issues and make recommendations to reduce this burden associated with health IT ​

• Working group with CMS ​

• ONC has initiated a working group with key staff from ONC and CMS to continue investigation into the PA ecosystem and identify areas for potential solutions

What's Needed to Develop Strategic Purchasing in Healthcare?

In the context of serious concerns over the affordability of healthcare, various authors and international policy bodies advise that strategic purchasing is a key means of improving health system performance. Such advice is typically informed by theories from the economics of organization (EOO). This paper proposes that these theories are insufficient for a full understanding of strategic purchasing in healthcare, because they focus on safeguarding against poor performance and ignore the coordination and adaptation needed to improve performance. We suggest that insights from other, complementary theories are needed. A realist review method was adopted involving three steps: first, drawing upon complementary theories from the EOO and inter-organizational relationships (IOR) perspectives, a theoretical interpretation framework was developed to guide the review; second, a purposive search of scholarly databases to find relevant literature addressing healthcare purchasing; and third, qualitative analysis of the selected texts and thematic synthesis of the results focusing on lessons relevant to three key policy objectives taken from the international health policy literature. Texts were included if they provided relevant empirical data and met specified standards of rigour and robustness. A total of 58 texts were included in the final analysis. Lessons for patient empowerment included: the need for clearly defined rights for patients and responsibilities for purchasers, and for these to be enacted through regular patient-purchaser interaction. Lessons for government stewardship included: the need for health strategy to contain specific targets to incentivise purchasers to align with national policy objectives, and for national government actors to build close, trusting relationships with purchasers to facilitate access to local knowledge about needs and priorities. Lessons for provider performance included: provider decision autonomy may drive innovation and efficient resource use, but may also create scope for opportunism, and interdependence likely to be the best power structure to incentivise collaboration needed to drive performance improvement. Using complementary theories suggests a range of general policy lessons for strategic purchasing in healthcare, but further empirical work is needed to explore how far these lessons are a practically useful guide to policy in a variety of healthcare systems, country settings and purchasing process phases.

The full article can be downloaded below.  

THE FOOD AND DRUG ADMINISTRATION’S POLICIES AND PROCEDURES SHOULD BETTER ADDRESS POSTMARKET CYBERSECURITY RISK TO MEDICAL DEVICES 

FDA had plans and processes for addressing certain medical device problems in the postmarket phase, but its plans and processes were deficient for addressing medical device cybersecurity compromises. Specifically, FDA's policies and procedures were insufficient for handling postmarket medical device cybersecurity events; FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices; and, in 2 of 19 district offices, FDA had not established written standard operating procedures to address recalls of medical devices vulnerable to cyber threats. These weaknesses existed because, at the time of our fieldwork, FDA had not sufficiently assessed medical device cybersecurity, an emerging risk to public health and to FDA's mission, as part of an enterprise risk management process. We shared our preliminary findings with FDA in advance of issuing our draft report. Before we issued our draft report, FDA implemented some of our recommendations. Accordingly, we kept our original findings in the report, but, in some instances, removed our recommendations.

We recommend that FDA do the following: (1) continually assess the cybersecurity risks to medical devices and update, as appropriate, its plans and strategies; (2) establish written procedures and practices for securely sharing sensitive information about cybersecurity events with key stakeholders who have a “need to know”; (3) enter into a formal agreement with Federal agency partners, namely the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team, establishing roles and responsibilities as well as the support those agencies will provide to further FDA's mission related to medical device cybersecurity; and (4) ensure the establishment and maintenance of procedures for handling recalls of medical devices vulnerable to cybersecurity threats. FDA agreed with our recommendations and said it had already implemented many of them during the audit and would continue working to implement the recommendations in the report. However, FDA disagreed with our conclusions that it had not assessed medical device cybersecurity at an enterprise or component level and that its preexisting policies and procedures were insufficient. We appreciate the efforts FDA has taken and plans to take in response to our findings and recommendations, but we maintain that our findings and recommendations are valid.

The full Office of Inspector General report can be downloaded below.  

The opportunities and challenges of data analytics in health care

This report is part of "A Blueprint for the Future of AI," a series from the Brookings Institution that analyzes the new challenges and potential policy solutions introduced by artificial intelligence and other emerging technologies.  This report specifically addresses topics such as sensitivity of care decisions, problematic data conventions, institutional practices, misaligned incentives, and ultimately concludes with policy recommendations.

The full report can be viewed at this link.  

The LAN was launched in March 2015 to accelerate the adoption of alternative payment models (APM) and drive alignment in payment reform approaches across the public and private sectors. These payment models have the potential to realign treatment and payment incentives to improve health care quality while containing cost. Through the LAN’s collaborative structure, more than 7,100 participants are taking action towards APM adoption and implementation. The LAN has adopted the goal of tying 50% of U.S. health care payments to APMs by the end of 2018. In 2016, the LAN embarked on its first national APM Measurement Effort to assess the adoption of APMs and the progress toward the LAN’s goals. The 2018 LAN APM Measurement Effort marks the third year of this initiative.

Developmental roadmap for antimicrobial susceptibility testing systems

Antimicrobial susceptibility testing (AST) technologies help to accelerate the initiation of targeted antimicrobial therapy for patients with infections and could potentially extend the lifespan of current narrow-spectrum antimicrobials. Although conceptually new and rapid AST technologies have been described, including new phenotyping methods, digital imaging and genomic approaches, there is no single major, or broadly accepted, technological breakthrough that leads the field of rapid AST platform development. This might be owing to several barriers that prevent the timely development and implementation of novel and rapid AST platforms in health-care settings. In this Consensus Statement, we explore such barriers, which include the utility of new methods, the complex process of validating new technology against reference methods beyond the proof-of-concept phase, the legal and regulatory landscapes, costs, the uptake of new tools, reagent stability, optimization of target product profiles, difficulties conducting clinical trials and issues relating to quality and quality control, and present possible solutions.

The full article can be downloaded below.