INTERNATIONAL INSTITUTE OF LAW AND TECHNOLOGY conduct courses in international centers

Professor Samuel D. Bernal
MD, PhD, JD, LLM, MBA

Course Description:

New molecular and cellular technologies applied to health have already resulted in improved diagnosis and treatment of various human diseases and offered better quality of life to patients all over the world. However, the rapid emergence of these technologies coming from the basic sciences has created numerous challenges in establishing legal and regulatory frameworks in research and clinical application. Different approaches and attitudes to these technologies in aspects ranging from moral, ethical, political to economic aspects have led to conflict of laws and regulations. These challenging issues are confronting lawyers in various fields including health law, drug and device regulatory law, intellectual property law and trade law. To understand the impact of these technologies, lawyers need a deep appreciation of the interrelationships of Law, Science, Medical Practice, Business, Economics, Religion, Ethics and Consumer Relations in the era of the Internet. This course will focus on some of the new and emerging technologies applied to health in the context of legal practice.

Aims of the Course:

At the end of the course students should be able to:

1. gain insights into the legal implications of recent advances in health technologies … ;

2. develop an understanding of the legal basis of regulations in genetic, molecular and cellular technologies applied to health … ;

3. create a framework to understand the legal basis for litigation in new health technologies … ;

4. make reasoned decisions about approaches in providing legal advice to commercial companies, non-profit organizations, academic institutions and governmental agencies on new health technologies … ;

5. make deductions based on acquired knowledge about the various factors that influence legal issues and decisions on regulations and litigation involving new health technologies… ;

6. interpret the scientific and technological information in the context of the legal framework for the applications of new health technologies…. ;

Course Outline: Law and Health Technology

I. Law and New Health Technologies:

A. Genetic Sequencing

1. In guiding diagnosis, prognostication and treatment of patients with cancer

2. In guiding diagnosis, prognostication and treatment of patients with degenerative diseases

3. In assessing genetic risk of development of cancer and degenerative diseases

4. In tracing genetic basis on inherited diseases

B. Gene Therapy

C. Molecular Tests

D. Molecular Therapies

E. Cellular Tests

F. Cellular Therapies and Stem Cells

II. Law of Privacy and Patient Information

III. Law, Information Technology and Health

IV. Law, Telemedicine and Mobile Health Technologies – Regulation and Liability

V. Patents and their influence on regulation, commercialization and litigation in new health technologies

A. Patenting gene sequences

B. Patenting genetic technologies

C. Patenting living cells and cellular technologies,