Personal Genome Medicine The Legal and Regulatory Transformation of US Medicine (Original PDF from Publisher)

1.1.Description

In the aftermath of FDA approval for direct-to-consumer genetic-health-risk testing, a phenomenon has unfolded where millions of individuals in the United States are entrusting their DNA to companies for personal genetic health risk information, bypassing the involvement of physicians or other trained medical professionals.

Michael J. Malinowski, in his work “Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” meticulously examines the ethical, legal, and societal ramifications stemming from this paradigm shift.

By assimilating insights from the historical and contemporary landscape of U.S. medicine, Malinowski employs a multifaceted approach encompassing law, policy, public and private sector practices, and governing norms to scrutinize the commercial personal genome sequencing and testing sectors.

Moreover, the book, presented in accessible language, not only analyzes the current landscape but also advocates for regulatory reforms.

These proposed reforms, targeted at both governmental bodies and medical professionals, aim to facilitate technological progress while upholding the standards of personal and public health.

Personal Genome Medicine

1.2.Key Features

The key features of “Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” include:

1. Exploration of Ethical, Legal, and Social Implications: “Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” delves into the ethical, legal, and social implications arising from the widespread adoption of direct-to-consumer genetic-health-risk testing, providing a comprehensive analysis.

2. Examination of Commercial Genome Sequencing and Testing Sectors: Michael J. Malinowski thoroughly analyzes the landscape of commercial personal genome sequencing and testing sectors, considering various factors such as law, policy, public and private sector practices, and governing norms.

3. Assessment of Impact on U.S. Medicine: “Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” assesses the impact of the aforementioned developments on the future of U.S. medicine, offering insights into how this transformative shift influences healthcare practices, patient-doctor relationships, and overall healthcare delivery.

4. Accessible Language: Written in relatable and accessible language, the book ensures that its insights are approachable to a wide audience, making complex legal and regulatory concepts understandable to readers beyond the legal and medical professions.

5. Proposal of Regulatory Reforms: Beyond analysis, the book goes a step further by proposing regulatory reforms. These reforms are designed to strike a balance between enabling technological advancements in genomics and maintaining standards for personal and public health.

6. Balancing Technological Progress and Health Standards: A central theme involves advocating for regulatory changes that foster technological progress in the field of genomics while simultaneously upholding crucial standards related to personal and public health.

7. Integration of Historical and Contemporary Perspectives: Malinowski integrates insights from both the historical and contemporary contexts of U.S. medicine, providing a nuanced understanding of the evolving landscape.

Overall, “Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” stands out as a comprehensive and accessible resource that not only analyzes the current state of genetic-health-risk testing but also offers thoughtful proposals for navigating the legal and regulatory aspects of this transformative field within the broader framework of U.S. medicine.

Personal Genome Medicine

Summary

“Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine” by Michael J. Malinowski explores the profound impact of direct-to-consumer genetic-health-risk testing on the landscape of U.S. medicine.

This comprehensive work scrutinizes the ethical, legal, and societal implications of individuals obtaining personal genetic health risk information without traditional medical professional involvement.

Malinowski employs a multidimensional approach, incorporating law, policy, sector practices, and governing norms to analyze the burgeoning commercial personal genome sequencing and testing sectors.

Written in accessible language, the book not only evaluates the current state of affairs but also proposes regulatory reforms aimed at navigating the evolving intersection of genomics, healthcare, and individual autonomy.

Balancing the transformative potential of genomic technology with the imperative to uphold personal and public health standards, the book serves as a valuable resource for understanding and shaping the future of genetic medicine in the United States.

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