HLTH07038 2020 Legal and Regulatory Practices in Health

General Details

Full Title
Legal and Regulatory Practices in Health
Transcript Title
Legal and Regulatory Practices
Code
HLTH07038
Attendance
N/A %
Subject Area
HLTH - Health Studies
Department
HEAL - Health & Nutritional Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Thomas Smyth, Richeal Burns
Programme Membership
SG_SINFO_B07 202000 Bachelor of Science in Health and Medical Information Science
Description

The aim of this module is to provide students with an understanding of the legal frameworks and regulatory practices which govern the delivery of healthcare services. The module will focus predominantly on the Irish healthcare setting with some comparative discussion on variation in regulatory frameworks in the UK, the USA and Australia. The regulation of healthcare is in the public interest and ensures that practices and outcomes are consistent with the aims and objectives set out by national and international best practice guidelines.  

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

To become familiar with the goals of regulatory frameworks adopted by the healthcare delivery systems at the national and international level

2.

To understand the evolving nature of legal and regulatory practices in healthcare delivery with the emergence of eHealth technologies and legislation around GDPR and associated challenges

3.

To critically assess whether legal and regulatory strategies provide better environments for patients and carers

4.

To examine the legal and regulatory implications for conducting medical research in the area of genome sequencing and personalised medicine

Teaching and Learning Strategies

Teaching and learning for this module will be carried out through a combination of online lectures, computer based critical appraisal and online practical's. Blended learning approaches will be adapted consistent with digital learning paradigms. 

Online delivery of 1 lecture per week with self directed learning. Guidance provided on relevant areas for self directed learning.

Online delivery of 2 hour workshop weekly, where students will be directed to complete interactive type activities to enhance their study skills and knowledge.

Question and answer sessions provided in the live classroom.

A variety of methods of instruction such as discussion, group work, interactive exercises, use of online resources and/or use of audio/visual material will be provided. Core skills will be embedded into all modules to ensure all students have an equal opportunity to succeed. This may include academic writing, oral presentations, reading techniques or research abilities. Accessible materials will be provided to students, including slides, documents, audio/visual material and textbooks enabling students slow down speed up recordings etc in accordance with universal distance learning.

All module content will be based on the principles of UDL to ensure equitable access to content and learning.

Module Assessment Strategies

This module will be assessed by both a final exam (50%) and continuous assessment (50%).

Repeat Assessments

Repeat examination will follow a similar format as applicable.

Indicative Syllabus

Origins of legal and regulatory frameworks in healthcare including international best practice guidelines; legal and regulatory practice in the Irish healthcare system; critical review of comparative healthcare systems regulatory practices; current challenges in regulation of healthcare delivery including resource allocation constraints, eHealth and telemedicine, GDPR, private/public delivery and contracts; regulatory practices and patient outcomes; future challenges for legal and regulatory practices in the evolving medical research landscape of genome sequencing and personalised medicine.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 CA1: Essay on current challenges in regulatory reform Continuous Assessment Assessment 20 % Week 6 1,2,3,4
2 CA2: Group project on case study review Continuous Assessment Assessment 30 % Week 11 1,3
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of Term Exam Final Exam Closed Book Exam 50 % End of Term 1,2,3,4
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 1 Weekly 1.00
Problem Based Learning Online Problem-based Learning Practical 2 Weekly 2.00
Independent Learning Not Specified Independent Learning 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2017-06-22 Medical Law in Ireland Kluwer Law International B.V.
ISBN 9789041195005 ISBN-13 9041195009

Derived from the renowned multi-volume International Encyclopaedia of Laws, this convenient volume provides comprehensive analysis of the law affecting the physician-patient relationship in Ireland. Cutting across the traditional compartments with which lawyers are familiar, medical law is concerned with issues arising from this relationship, and not with the many wider juridical relations involved in the broader field of health care law. After a general introduction, the book systematically describes law related to the medical profession, proceeding from training, licensing, and other aspects of access to the profession, through disciplinary and professional liability and medical ethics considerations and quality assurance, to such aspects of the physician-patient relationship as rights and duties of physicians and patients, consent, privacy, and access to medical records. Also covered are specific issues such as organ transplants, human medical research, abortion, and euthanasia, as well as matters dealing with the physician in relation to other health care providers, health care insurance, and the health care system. Succinct and practical, this book will prove to be of great value to professional organizations of physicians, nurses, hospitals, and relevant government agencies. Lawyers representing parties with interests in Ireland will welcome this very useful guide, and academics and researchers will appreciate its comparative value as a contribution to the study of medical law in the international context.

Required Reading
2016-10-20 Medical Ethics, Law and Communication at a Glance John Wiley & Sons
ISBN 9781119266167 ISBN-13 1119266165

Medical Ethics, Law and Communication at a Glance presents a succinct overview of these key areas of the medical curriculum. This new title aims to provide a concise summary of the three core, interlinked topics essential to resolving ethical dilemmas in medicine and avoiding medico-legal action. Divided into two sections; the first examines the ethical and legal principles underpinning each medical topic; while the second focuses on communication skills and the importance of good communication. Medical Ethics, Law and Communication at a Glance offers an accessible introduction to the fundamentals of good medical practice, and will provide indispensable support for undergraduate medical students and nurses, as well as newly qualified healthcare professionals.

Required Reading
2013-03-14 European Law and New Health Technologies OUP Oxford
ISBN 9780191634840 ISBN-13 0191634840

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money. To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation. This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

Module Resources

Other Resources

A range of online resources and applications will be used.