The Compelling Need for Shared Responsibility of AI Oversight: Lessons From Health IT Certification.

This Viewpoint highlights the potential for artificial intelligence (AI) health care tools to introduce unintended patient harm; calls for an efficient, rigorous approach to AI testing and certification that is the shared responsibility of developers and users; and makes recommendations to inform such an approach.

Fourth Amendment Protections of Health Information After Carpenter v. United States: The Devil's In The Database.

Every day, companies collect health information from customers and analyze it for commercial purposes. This poses a significant threat to privacy, particularly as the Fourth Amendment protection of this deeply personal information is limited. Generally, law enforcement officers do not need probable cause and a warrant to access these private health information databases; only a subpoena is required, and sometimes nothing at all. The Fourth Amendment protections for health information may, however, have changed after the Supreme Court's 2018 decision in Carpenter v. United States, which held that the Fourth Amendment protects people from warrantless searches of historical cell-site location information possessed by their cell phone providers. The Court explained that, because of the nature of historical cell-site location information, individuals retain a reasonable expectation of privacy despite the information being in the possession of a third party. In reaching its holding, the Supreme Court considered the type of data, the uniqueness of cell-site location information, the impact of technological advancement on privacy, the voluntariness of the disclosure, and the property rights associated with the records. Many of these factors could support heightened Fourth Amendment protection for health information. This Article argues that Carpenter v. United States provides additional protections for future searches of health information in private databases.

Relevance of eHealth standards for big data interoperability in radiology and beyond.

The aim of this paper is to report on the implementation of radiology and related information technology standards to feed big data repositories and so to be able to create a solid substrate on which to operate with analysis software. Digital Imaging and Communications in Medicine (DICOM) and Health Level 7 (HL7) are the major standards for radiology and medical information technology. They define formats and protocols to transmit medical images, signals, and patient data inside and outside hospital facilities. These standards can be implemented but big data expectations are stimulating a new approach, simplifying data collection and interoperability, seeking reduction of time to full implementation inside health organizations. Virtual Medical Record, DICOM Structured Reporting and HL7 Fast Healthcare Interoperability Resources (FHIR) are changing the way medical data are shared among organization and they will be the keys to big data interoperability. Until we do not find simple and comprehensive methods to store and disseminate detailed information on the patient's health we will not be able to get optimum results from the analysis of those data.

Assessing HITECH Implementation and Lessons: 5 Years Later.

POLICY POINTS: The expansive goals of the Health Information Technology for Economic and Clinical Health (HITECH) Act required the simultaneous development of a complex and interdependent infrastructure and a wide range of relationships, generating points of vulnerability. While federal legislation can be a powerful stimulus for change, its effectiveness also depends on its ability to accommodate state and local policies and private health care markets. Ambitious goals require support over a long time horizon, which can be challenging to maintain. The future of health information technology (health IT) support nationally is likely to depend on the ability of the technology to satisfy its users that its functionalities address the interests policymakers and other stakeholders have in using technology to promote better care, improved outcomes, and reduced costs. CONTEXT: The Health Information Technology for Economic and Clinical Health (HITECH) Act set ambitious goals for developing electronic health information as one tool to reform health care delivery and improve health outcomes. With HITECH's grant funding now mostly exhausted but statutory authority for standards remaining, this article looks back at HITECH's experience in the first 5 years to assess its implementation, remaining challenges, and lessons learned. METHODS: This review derives from a global assessment of the HITECH Act. Earlier, we examined the logic of HITECH and identified interdependencies critical to its ultimate success. In this article, we build on that framework to review what has and has not been accomplished in building the infrastructure authorized by HITECH since it was enacted. The review incorporates quantitative and qualitative evidence of progress from the global assessment and from the evaluations funded by the Office of the National Coordinator for Health Information Technology (ONC) of individual programs authorized by the HITECH Act. FINDINGS: Our review of the evidence provides a mixed picture. Despite HITECH's challenging demands, its complex programs were implemented, and important changes sought by the act are now in place. Electronic health records (EHRs) now exist in some form in most professional practices and hospitals eligible for HITECH incentive payments, more information is being shared electronically, and the focus of attention has shifted from adoption of EHRs toward more fundamental issues associated with using health information technology (health IT) to improve health care delivery and outcomes. In some areas, HITECH's achievements to date have fallen short of the hopes of its proponents as it has proven challenging to move meaningful use beyond the initial low bar set by Meaningful Use Stage 1. EHR products vary in their ability to support more advanced functionalities, such as patient engagement and population-based care management. Many barriers to interoperability persist, limiting electronic communication across a diverse set of largely private providers and care settings. CONCLUSIONS: Achieving the expansive goals of HITECH required the simultaneous development of a complex and interdependent infrastructure and a wide range of relationships, some better positioned to move forward than others. To date, it has proven easier to get providers to adopt EHRs, perhaps in response to financial incentives to do so, than to develop a robust infrastructure that allows the information in EHRs to be used effectively and shared not only within clinical practices but also across providers. Effective exchange of data is necessary to drive the kinds of delivery and payment reforms sought nationwide.

Electronic health records in rheumatology: emphasis on automated scoring and additional use.

Electronic health records are increasingly used and frequently required from various regulatory authorities. Apart from their day-to-day use by health care professionals for routine clinical practice and/or the improvement of quality of care processes, patients with chronic inflammatory disease may become increasingly involved in the data retrieval process by self-monitoring and providing patient-reported (outcome) data. Among key features of electronic health records are automated scoring, visualisation of validated measures, and long-term systematic patient-centered data collection in a structured and standardised manner. Data derived from electronic health records are increasingly incorporated into patient-centered research, registries, and other secondary uses. Thus, electronic health records offer opportunities to improve knowledge and to create new process flows in rheumatology health care. The article summarises some of these opportunities in patient care, as well as an overview of secondary use scenarios. In addition, the article focuses on patients' active involvement in the disease management process via health information applications, reports on patients' perspectives, as well as some legal and regulatory matters concerning electronic health records.

ONC Health IT Certification Program: Enhanced Oversight and Accountability. Final rule.

This final rule finalizes modifications and new requirements under the ONC Health IT Certification Program ("Program"), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The final rule creates a regulatory framework for ONC's direct review of health information technology (health IT) certified under the Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results.

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications. Final rule.

This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or "2015 Edition'') and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs.

[Modern aspects of organization of medical support for the Armed Forces].

The challenges that medical service of the Armed Forces of the Russian Federation faces cannot be solved without a new qualitative approach to military and medical support. In order to create a complete organizational system of the medical support, consisting of united process of material flow management and management of accompanying elements, the. structure of the medical support and its equipment must correspond to performed tasks. The article describes a set of activities that are performed in the system of military-medical support and offers some promising approaches, which are supposed to solve assigned tasks imposed upon the center of pharmacy and medical technology and its interaction with superior body control, maintainable and third party organizations.

CLIA program and HIPAA privacy rule; patients' access to test reports. Final rule.

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test. In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.

2014 Edition Release 2 Electronic Health Record (EHR) certification criteria and the ONC HIT Certification Program; regulatory flexibilities, improvements, and enhanced health information exchange. Final rule.

This final rule introduces regulatory flexibilities and general improvements for certification to the 2014 Edition EHR certification criteria (2014 Edition). It also codifies a few revisions and updates to the ONC HIT Certification Program for certification to the 2014 Edition and future editions of certification criteria as well as makes administrative updates to the Code of Federal Regulations.

Medicare and Medicaid programs; modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and other changes to EHR Incentive Program; and health information technology: revision to the certified EHR technology definition and EHR certification changes related to standards. Final rule.

This final rule changes the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT) to allow options in the use of CEHRT for the EHR reporting period in 2014. It also sets the requirements for reporting on meaningful use objectives and measures as well as clinical quality measure (CQM) reporting in 2014 for providers who use one of the CEHRT options finalized in this rule for their EHR reporting period in 2014. In addition, it finalizes revisions to the Medicare and Medicaid EHR Incentive Programs to adopt an alternate measure for the Stage 2 meaningful use objective for hospitals to provide structured electronic laboratory results to ambulatory providers; to correct the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission; and to set a case number threshold exemption for CQM reporting applicable for eligible hospitals and critical access hospitals (CAHs) beginning with FY 2013. Finally, this rule finalizes the provisionally adopted replacement of the Data Element Catalog (DEC) and the Quality Reporting Document Architecture (QRDA) Category III standards with updated versions of these standards.

The roles of federal legislation and evolving health care systems in promoting medical-dental collaboration.

Recent federal health care legislation contains explicit and implicit drivers for medical-dental collaboration. These laws implicitly promote health care evolution through value-based financing, "big data" and health information technology, increased number of care providers and a more holistic approach. Additional changes--practice aggregation, consumerism and population health perspectives--may also influence dental care. While dentistry will likely lag behind medicine toward value-based and accountable care organizations, dentists will be affected by changing consumer expectations.

Adding home health care to the discussion on health information technology policy.

The potential for health information technology to improve the efficiency and effectiveness of health care has resulted in several U.S. policy initiatives aimed at integrating health information technology into health care systems. However, home health care agencies have been excluded from incentive programs established through policies, raising concerns on the extent to which health information technology may be used to improve the quality of care for older adults with chronic illness and disabilities. This analysis examines the potential issues stemming from this exclusion and explores potential opportunities of integrating home health care into larger initiatives aimed at establishing health information technology systems for meaningful use.

Clinical informatics sub-specialty board certification.

Increased funding for health information technology and the advance of electronic health records in hospitals and practices have created the need for a new specialist: the clinical informatician. Clinical informatics was recognized in 2011 as the latest subspecialty in medicine by the American Board of Medical Specialties. This article reviews the need for this new specialty as well as the steps necessary for its creation. The content and training requirements for clinical informatics are discussed as well as eligibility criteria for taking the board examination. Training programs as well as board preparation are addressed along with the expected impact that this new field will have on the practice of medicine.