What you’ll learn

  • The major areas in FinTech, includingMoney and Payment,Digital Finance and Alternative Finance
  • Major technological trends, including cryptocurrencies, Blockchain, AI and Big Data
  • FinTech Regulation and RegTech
  • The fundamental role of Data and Security in data-driven finance
  • Business and regulatory implications of technology for the financial industry
  • How regulations and RegTech are applied
  • Ways to analyse and evaluate what is driving technology innovation in Finance
  • How new technology impacts economies, markets, companies, and individuals

Meet your instructors

Douglas Arner

Douglas W. Arner is the Kerry Holdings Professor in Law at the University of Hong Kong and Project Coordinator of a major five-year project funded by the Hong Kong Research Grants Council Theme-based Research Scheme on “Enhancing Hong Kong’s Future as a Leading International Financial Centre”. In addition, he is Director of the HKU LLM in Compliance and Regulation, and a Senior Visiting Fellow of Melbourne Law School, University of Melbourne. Douglas is a member of the Hong Kong Financial Services Development Council and an Executive Committee Member of the Asia Pacific Structured Finance Association. Douglas has served as a consultant with, among others, the World Bank, Asian Development Bank, APEC, European Bank for Reconstruction and Development, Islamic Financial Services Board and Development Bank of Southern Africa. He has lectured, co-organised conferences and seminars and been involved with financial sector reform projects in over 20 economies in Africa, Asia and Europe. He has been a visiting professor or fellow at Duke University, the Hong Kong Institute for Monetary Research, the Interdisciplinary Centre – Herzliya, McGill University, Melbourne University, National University of Singapore, University of New South Wales, Shanghai University of Finance and Economics, and Zurich University, among others. Douglas served as Head of the Department of Law of the University of Hong Kong from 2011 to 2014 and from 2006 to 2011 he was the Director of the Faculty’s Asian Institute of International Financial Law, which he co-founded in 1999 along with the LLM in Corporate and Financial Law (of which he serves as Director). He was Co-Director of the Duke University-HKU Asia-America Institute in Transnational Law from 2005 to 2016 and a member of the International Advisory Board of the Australian Centre for International Finance and Regulation from 2010-2016. In 2007, he received HKU’s Outstanding Young Researcher Award and served as Convenor of HKU’s Law, Policy and Development Strategic Research Theme from 2008-2012. Before joining HKU in 2000, he was the Sir John Lubbock Support Fund Fellow at the Centre for Commercial Law Studies, Queen Mary College, University of London.

Janos Barberis

Janos Barberis has an established track record in the FinTech industry (32nd Most Powerfull Dealmaker, Institutional Investor) and Academia (13th legal scholar in world, SSRN) and is driven to deliver actionable foresight. His area of focus on FinTech Regulation and RegTech Developments and emerging trends. Academically, he developed the world's leading research which is directly used by regulators for policy design. Professionally, he has founded SuperCharger, Asia's leading FinTech accelerator sponsored by Tier 1 clients and strong of an alumni network of 26 companies, which have raised in excess of US$370million. Finally, he co-edited, The FinTech Book, a global bestseller, covering 60 experts with over 20,000 copies distributed in 106 countries and 6 languages and is due to release three more titles in Q1 of 2018, including the world's first book on RegTech. In last 3 years, he has completed over 100 keynotes (i.e. SIBOS), private client workshops (i.e Natixis), professional training (i.e. CFA), regulators consultations (i.e. ADB) and online lectures (i.e. HKU). His work is regularly cited by the media (i.e. Forbes), industry (i.e. E&Y) or governments (i.e. FSB). He holds several board appointments (i.e. WEF, SFC) has published over a dozen academic article and is published in 5 books.

Huy Nguyen Trieu

Huy Nguyen Trieu is co-founder of the Centre for Finance, Technology and Entrepreneurship. He is also the CEO of The Disruptive Group – a business builder and advisory firm in innovation and finance. Prior to The Disruptive Group, Huy was a Managing Director at Citi, and previously at RBS and SG. Before banking, he was the CEO of Ukibi, a VC-funded startup in the US. He is a frequent keynote speaker in Europe and Asia, likes to teach and share with students and entrepreneurs, and is regularly quoted in articles on innovation and finance. He writes the blog Disruptive Finance, is a Fintech Fellow at the Centre for Global Finance and Technology at Imperial College, an Entrepreneurship Expert at Oxford Said Entrepreneurship Centre. He is also a member of ESMA’s Consultative Working Group for financial innovation and a founding member of the Asian SuperCharger, one of the largest Fintech accelerators in Asia.

Ross Buckley

Ross Buckley is King & Wood Mallesons Professor of International Finance Law, and a Scientia Professor, at UNSW Sydney, and Series Co-Editor of the Global Trade Law Series and International Banking and Finance Law Series, of Wolters Kluwer of The Hague. His research focus is FinTech, RegTech and blockchain and the enabling regulation of digital financial services in developing countries. He consults regularly to the Asian Development Bank, and has consulted to government departments in Australia, Indonesia, Vietnam and the U.S. He has been twice a Fulbright Scholar, and frequently a half-bright scholar.

About this course

Prescription drugs are among the most common health care interventions and have turned some once-fatal diseases into manageable conditions — but they have also been a growing source of controversy. Patients in the US struggle with increasing costs and express concerns about why many conditions, such as Alzheimer’s disease, remain without adequate therapeutic options.

At the center of these debates lies the US Food and Drug Administration (FDA), a federal agency responsible for monitoring the prescription drug marketplace and enforcing basic rules and laws that affect how prescription drugs are discovered, developed, and sold.

This course investigates the major issues affecting the regulatory approval and evidence-based use of prescription drugs. You will learn the rules and regulations governing the pricing, marketing, and safety monitoring of approved prescription drugs and the importance of the FDA in regulating key aspects of the pharmaceutical market.

Continuing Medical Education (CME)
Medical professionals who enroll in the verified track and successfully complete Module 2: Drug Development and Approval can earn AMA PRA Category 1 Credit™ (2 credits).

 

What you’ll learn

  • Key controversies over how prescription drugs are developed and marketed, and why those controversies exist
  • The FDA — its history, public health role, and rules affecting prescription drugs in the US
  • The process of discovering, testing, and approving innovative drugs, including various perspectives on the criteria used for drug approval
  • The cost of prescription drugs, including the factors affecting a drug’s market exclusivity period and the availability and use of affordable generic drugs
  • Safety evaluation of prescription drugs using “real world” data
  • Current topics stirring debate over the scope of FDA regulation, such as dietary supplements, special classes of prescription drugs, and “right to try” laws that allow patients to obtain drugs prior to FDA approval
  • Prescription drug marketing rules and the effect of drug promotion on the behavior of physicians and patients

Prerequisites

None

Frequently asked questions

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How does my participation contribute to research?
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Harvard University and HarvardX are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program. All members of the HarvardX community are expected to abide by Harvard policies on nondiscrimination, including sexual harassment, and the edX Terms of Service. If you have any questions or concerns, please contact harvardx@harvard.edu and/or report your experience through the edX contact form.

Meet your instructors

Aaron Kesselheim

Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University
Aaron S. Kesselheim MD JD MPH is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (PORTAL, www.PORTALresearch.org), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. PORTAL is now among the most prolific independent academic centers focusing on these issues in the country (Twitter: @PORTAL_research, @akesselheim). Work by faculty members at PORTAL on this course has been supported by a grant from Arnold Ventures.

Ameet Sarpatwari

Assistant Professor of Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University
Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. Among other projects, he is currently examining the public health impact of risk evaluation and mitigation strategies, the comparative safety and effectiveness of authorized and non-authorized generics, and the effect of variation in state drug product selection laws on generic drug prescribing.

Jonathan Darrow

Assistant Professor of Medicine, Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital at Harvard University
Jonathan J. Darrow joined the faculty of Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in 2016, following service as Senior Law Clerk to a judge on the United States Court of Appeals for the Federal Circuit, the court that decides all patent appeals involving pharmaceuticals, biologics, and medical devices. He holds degrees in biological sciences / genetics, law, and business from Cornell, Duke, and Boston College, respectively, as well as a research doctorate in pharmaceutical policy and intellectual property theory from Harvard, where he also completed the LL.M. program. He has been qualified as a patent attorney since 2002. After admission to the California bar, Dr. Darrow worked on pharmaceutical litigation matters at Wiley Rein & Fielding in Washington , DC, served on the business law faculties of several universities, and explored the relationship between innovation policy and global health during stints at the World Trade Organization, the World Health Organization, and the World Intellectual Property Organization. He is a co-author of three textbooks, including Cyberlaw: Management & Entrepreneurship (2015) and The Legal and Ethical Environment of Business (2014). His scholarship on health policy and intellectual property has appeared in the British Medical Journal, the New England Journal of Medicine; the Journal of Law, Medicine & Ethics; the Stanford Technology Law Review; the Yale Journal of Health Policy Law & Ethics, and the Harvard Journal of Law & Technology, among many others, and he has testified before a committee of the Massachusetts legislature on an emerging issue of law and technology.

Jerry Avorn

Professor of Medicine, Emeritus Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics and Co-Director of the Program On Regulation, Therapeutics, And Law at Harvard University
Dr. Avorn is Professor of Medicine at Harvard Medical School and Emeritus Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics and Co-Director of PORTAL. A general internist, geriatrician, and drug epidemiologist, he pioneered the concept of academic detailing and is recognized as a leading expert on this topic and on optimal medication use, particularly in the elderly.

About this course

Bioethics provides an overview of the legal, medical, and ethical questions around reproduction and human genetics and how to apply legal reasoning to these questions.

This law course includes interviews with individuals who have used surrogacy and sperm donation, with medical professionals who are experts in current reproductive technologies like In Vitro Fertilization and Preimplantation Genetic Diagnosis, and bioethicists and journalists who study the ownership and use of genetic information within human tissue. Additional Harvard colleagues will also share with you their thoughts on topics such as disability law as it relates to reproductive technology.

While the law and ethics surrounding these technologies are a central component to this course, we also show you examples of the deeply personal and human side of these issues. Throughout the course, and with the help of law students, we will discuss leading legal cases in this field, which will illuminate the types of questions the law has struggled with – stretching and evolving over time. From the famous Baby M surrogacy case, to cases on the paternity of sperm donors, to a case related to the ownership of human tissue turned into a commercial product, and others. We will show you the ethical, legal, and rhetorical underpinnings, which have served as the basis for various court decisions over the past 20 or 30 years. We will also explore potential future technologies and their implications for society: genetic enhancements to increase our intelligence, let us live a hundred years longer, or make us immune to diseases – and the possibility of creating animal-human hybrids, for example a mouse with a humanized brain.

The content within this course is intended to be instructive, and show how legal reasoning has been applied, or could be applied, to questions related to parenthood, reproduction, and other issues surrounding human genetic material. The material organized within this course should be considered an authoritative overview, but is not intended to serve as medical or legal advice.

What you’ll learn

  • How the reproductive technology industry works, and issues raised related to buying and selling human reproductive materials
  • The law and ethics of surrogacy
  • Civil lawsuits when things go wrong with reproductive technology: wrongful birth and wrongful life lawsuits
  • The law and ethics of sperm donation and the legal status of sperm donors
  • thical and legal issues raised by human enhancement
  • The law and ethics of mixing human and animal genetic material
  • The ownership of human tissue and its underlying genetic information

HarvardX Honor Code
HarvardX requires individuals who enroll in its courses on edX to abide by the terms of the edX honor code. HarvardX will take appropriate corrective action in response to violations of the edX honor code, which may include dismissal from the HarvardX course; revocation of any certificates received for the HarvardX course; or other remedies as circumstances warrant. No refunds will be issued in the case of corrective action for such violations. Enrollees who are taking HarvardX courses as part of another program will also be governed by the academic policies of those programs.

HarvardX Nondiscrimination/Anti-Harassment Statement
Harvard University and HarvardX are committed to maintaining a safe and healthy educational and work environment in which no member of the community is excluded from participation in, denied the benefits of, or subjected to discrimination or harassment in our program. All members of the HarvardX community are expected to abide by Harvard policies on nondiscrimination, including sexual harassment, and the edX Terms of Service. If you have any questions or concerns, please contact harvardx@harvard.edu and/or report your experience through the edX contact form.

HarvardX Research Statement
HarvardX pursues the science of learning. By registering as an online learner in an HX course, you will also participate in research about learning. Read our research statement to learn more.

Meet your instructors

I. Glenn Cohen

Professor, Harvard Law School at Harvard University
Professor I. Glenn Cohen is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Professor Cohen has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34), though not the youngest in history. Professor Cohen's current projects relate to big data, health information technologies, mobile health, reproduction/reproductive technology, research ethics, organ transplantation, rationing in law and medicine, health policy, FDA law, translational medicine, and to medical tourism – the travel of patients who are residents of one country, the "home country," to another country, the "destination country," for medical treatment.

About this course

This course is part of the Healthcare Administration MicroMasters program which consists of 7 courses and a capstone exam. After completing the program, you can also apply to Doane University to complete your MBA online for approximately $10,500 (learn more about the program here).

To be an effective agent of change, a healthcare administrator must have a foundational understanding of healthcare advocacy, law, and regulatory issues, as well as compliance. This course will focus on a wide range of important issues in health law, health policy and the factors at play when developing a strategic advocacy platform such as bioethics and informed consent. At the conclusion of this course, learners will be able to identify health policies that promote quality, advocacy and system change within a healthcare organization.

What you’ll learn

  • Discuss health law
  • Explain physician-patient relations within a legal context
  • Interpret laws that shape access to health care
  • Explore informed consent for medical treatment
  • Evaluate medical malpractice suits within healthcare systems
  • Inspect the utilization of bioethics in healthcare
  • Describe methods for advocating in healthcare systems.
  • Identify culturally competent advocacy strategies
  • Assess a health policy change that promotes quality, advocacy and system change.

Prerequisites

  • Bachelor’s degree or
  • Minimum 5 years work experience in a healthcare related field
  • Basic understanding of economics and finance

Who can take this course?

Unfortunately, learners from one or more of the following countries or regions will not be able to register for this course: Iran, Cuba and the Crimea region of Ukraine. While edX has sought licenses from the U.S. Office of Foreign Assets Control (OFAC) to offer our courses to learners in these countries and regions, the licenses we have received are not broad enough to allow us to offer this course in all locations. EdX truly regrets that U.S. sanctions prevent us from offering all of our courses to everyone, no matter where they live.

Meet Your Instructors

Alice Kindschuh - Pearson Advance

Alice Kindschuh

DNP, APRN-CNS, CNE at Doane University
Dr. Alice Kindschuh is a Board Certified Gerontological Clinical Nurse Specialist and is licensed as an Advanced Practice Nurse in Nebraska. Prior nursing experiences include staff nurse and nurse manager in acute, long term, and ambulatory care. She has served as a faculty member in ADN, BSN, and MSN programs prior to coming to Nebraska Methodist College. Dr. Kindschuh is a full time faculty member at Nebraska Methodist College, serving as the Director of Doctoral Studies. She is active in several professional groups and boards including Nebraska Nurse's Association, National Gerontological Nursing Association, Sigma Theta Tau, Midwest Nursing Research Society, and the Nebraska Advanced Nursing Practice Board. Areas of Expertise: higher education geriatrics population health
Susan Sapp - Pearson Advance

Susan Sapp

JD at Doane University
Susan Sapp has a general civil trial practice which includes labor and employment issues, medical and legal malpractice defense and insurance defense. She represents school districts, hospitals, doctors, employers and insurance companies in all aspects of legal representation. She also handles all aspects of adoption proceedings. In addition, Susan serves as mediator in personal injury and employment cases. Susan is admitted to practice law in Nebraska, Iowa, the United States District Court for the District of Nebraska, and the United States Court of Appeals for the Eighth Circuit.