oles dr john m (4 risultati)

Condizione: New. Print on Demand.

Condizione: New. Print on Demand.

Paperback. Condizione: new. Paperback. Precision medicine programs are among the most data-intensive, regulatory-complex, and ethically consequential initiatives that health systems and research institutions undertake today. Yet the professionals charged with leading them - program directors, clinical informaticists, compliance officers, bioinformaticians, and health system administrators - have had no single authoritative resource that addresses the full governance and management landscape they must navigate.Mastering Precision Medicine Data Systems fills that gap. Written for graduate students in biomedical informatics, health administration, and clinical genetics, as well as working professionals managing large-scale precision medicine initiatives, this textbook provides the conceptual frameworks, governance methodologies, and practical tools needed to plan, operate, and evaluate precision medicine programs that are scientifically rigorous, regulatory-compliant, and ethically accountable.Across fifteen chapters, the book develops an integrated treatment of the four governance domains that define modern precision medicine practice.The data infrastructure domain covers omics data architecture, next-generation sequencing pipelines, cloud and federated storage systems, and the interoperability standards - HL7 FHIR, SNOMED CT, LOINC - through which genomic and clinical data are integrated.The regulatory and compliance domain provides comprehensive, applied treatment of HIPAA's application to genomic data, the Common Rule's evolving consent frameworks, FDA regulation of AI-based diagnostic tools, the 21st Century Cures Act's information-blocking provisions, and the GDPR's heightened requirements for genetic data as a special category of personal information.The artificial intelligence governance domain addresses the full AI/ML model lifecycle - development, validation, deployment, monitoring, and retirement - with particular attention to algorithmic fairness, explainability requirements, FDA SaMD pathways, and the institutional governance structures through which clinical AI systems are accountably managed.The ethics and equity domain weaves principles of biomedical ethics, participant rights, return-of-results governance, and health equity through every chapter, treating equity not as a supplementary concern but as a core governance obligation.The book's final chapters and appendices translate governance frameworks into operational tools: a HIPAA compliance checklist specific to genomic data environments, a complete data use agreement template, an AI model governance policy framework with deployment approval workflows and fairness thresholds, a comprehensive glossary of over eighty precision medicine data governance terms, and a regulatory reference guide spanning US federal law, GDPR, and key international frameworks.Each chapter includes learning objectives, case-based exercises grounded in realistic program scenarios, discussion questions designed for graduate seminar use, and curated further reading drawn from the primary literature. The result is a textbook that bridges the gap between policy and practice - giving readers not only the conceptual vocabulary to understand precision medicine governance but the analytical tools to exercise it in the complex, multi-stakeholder, rapidly evolving environments where precision medicine programs operate. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.

Paperback. Condizione: new. Paperback. Precision medicine has arrived in the clinic. Genomic testing panels are embedded in oncology protocols, pharmacogenomic alerts fire in EHR workflows, hereditary risk programs counsel thousands of patients annually, and health systems are making nine-figure investments in the informatics infrastructure that makes molecularly guided care possible.What has not kept pace is the administrative infrastructure required to sustain it.Genomic testing reimbursement is contested, payer-specific, and perpetually evolving. HIPAA's application to genomic data involves re-identification risks and regulatory gray zones that standard privacy training does not address. ICD and CPT coding for molecular diagnostics requires specialized expertise that most revenue cycle departments do not yet possess. And the organizational change management required to integrate precision medicine workflows into existing clinical operations - across departments, facilities, and care settings that were not designed with molecular data in mind - demands administrative leadership of exceptional sophistication.The regulatory compliance section provides the most operationally complete treatment of HIPAA's application to genomic data environments available for administrative audiences. It covers the business associate agreement landscape for genomic vendors and cloud providers, the de-identification limitations unique to genomic sequences, the Common Rule's consent requirements for biobanking and secondary research use, the 21st Century Cures Act's information-blocking provisions as they apply to genomic test results in designated record sets, and the FDA regulatory framework governing AI-based clinical decision support tools increasingly embedded in precision medicine workflows. International compliance considerations - GDPR's classification of genetic data as a special category of sensitive personal information, PIPEDA requirements for Canadian operations - are addressed for health systems with international patient populations or research collaborations.Revenue cycle management for precision medicine receives the sustained, expert treatment it has never before received in textbook form. The book addresses the complete billing and reimbursement lifecycle for molecular diagnostic services: CPT coding for genomic panels, single-gene tests, pharmacogenomic assays, and liquid biopsy procedures; ICD-10-CM coding for genomic indications and hereditary risk conditions; Medicare coverage policies including MolDx program requirements and local coverage determinations that govern reimbursement for next-generation sequencing panels; Medicaid and commercial payer prior authorization strategies for high-cost genomic tests; appeals and denial management specific to molecular diagnostic claims; and the financial modeling frameworks health system administrators need to evaluate the return on precision medicine program investment across clinical, research, and operational dimensions.The book closes with a forward-looking treatment of the administrative landscape precision medicine is creating: value-based care contracting for genomic medicine, the administrative implications of polygenic risk score integration into preventive care programs, the facility planning requirements of spatial transcriptomics and next-generation diagnostic platforms, and the equity dimensions of precision medicine access that health system administrators have both an ethical obligation and a strategic interest in addressing. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.