Ow can insurance be used to decrease healthcare costs and increase quality of care?

Legal, Ethical & Social Issues
In Medical Informatics The Course


Session 1:

3 branches of federal government
Separation of powers
Checks & balances
Civil vs. criminal laws

Key government regulators:
DHHS
CMS
HHS OIG
TJC
DOJ


Session 2:

HIPAA
Covered entities
Business associate
BA Agreement
Minimum necessary standard
PHI
Treatment
Payment
Healthcare Operations
Uses & disclosures of PHI
Incidental uses & disclosures of PHI
Various methods of de-identifying data, per HIPAA
Chief privacy officer/Chief security officer
Limited data set
3 kinds of HIPAA security safeguards
HIPAA security risk management
Appropriately handling a HIPAA violation when you see one


Session 3:

Role of informaticists in a healthcare organization s compliance program
Fraud & Abuse definition
2 key federal healthcare programs protected by F&A laws
3 key government regulators with oversight of fed HC programs
Civil False Claims Act
 Knowing standards  civil
Qui tam relators
Criminal False Claims Act
Anti-Kickback Law
Exceptions to Anti-Kickback Law
Stark Law
Safe harbors to Stark Law
Obstruction of Justice
F&A legal barriers to EHR and the proposed safe harbor
Corporate compliance
Federal Sentencing Guidelines
7 elements of effective compliance program, per Fed Sentencing Guidelines
Importance of effective compliance program
Risks of ineffective compliance program
Why  process is a key compliance concept
Transparency
Accountability
Conflict of interest
Undue influence


How the concepts of transparency and accountability are relevant to the work of a medical informaticist


Session 4:

Alternative approaches to reporting bad news to a C-level executive about an IT legal /ethics/compliance issue arising from data handling


Roles of corporate legal counsel in medical informatics field


Session 5:


Ethical issues arising from clinical data handling and reporting
Social issues arising from clinical data handling and reporting
Justice
Non-maleficence
Autonomy
Beneficence
Consequential Moral Theories
Egoism
Utilitarianism
Virtue Ethics
Consider roles of law, religion & custom in resolving an ethical dilemma
Deontological Moral Theories
Feminist Critiques
Narrative Ethics
Communicative Ethics


Address an ethical dilemma from the different perspectives of several alternative moral theories


Session 6:

Regulatory informatics
What is the Hospital Quality Alliance
QIO
What is National Quality Forum s role regarding quality measures
TJC s patient care quality measures
What is mission of The Leapfrog Group
Sentinel Event
Reviewable Sentinel Events
Root Cause Analysis
Action Plan
Role of informaticist in root cause analyses
ORYX Initiative and Core Measures
AHRQ s National Health Data Stewardship Entity
The Joint Commission (TJC)
Accredited healthcare organization
Conditions of Participation (CoP)
Deemed status
Deeming authority
 Recognition & reliance concept
TJC Standard
TJC Element of Performance


Session 7:

Legal barriers to EHR
Goals and purposes of antitrust laws
Sherman Act
Clayton Act
2 antitrust enforcement agencies
Antitrust statute of limitations
Treble damages

4 Per se antitrust violations
Price fixing
Market allocation/division
Boycotts/ concerted refusal to deal
Tying arrangements


Antitrust safety zones/safe harbors

Statement 4
Statement 5
Statement 6

The Survey Exception


Sessions 8 10:

Intellectual Property (IP)


Copyright
Trademark
Registered Trademark
Service Mark
How to Preserve Patent Rights
Trade Secrets
Contractual IP Protection
IP Notices for copyright and trademark
The Fair Use Doctrine (know how to apply 6 factors)
Public policy considerations for Fair Use of copyrighted works
Intellectual Asset Management Systems (IAM)


Role of informaticist in protecting and preserving your organization s rights to its IP assets, including protection of ideas and what to preserve for legal counsel s use in obtaining legal protections for a new IP asset

The assignment The Research Paper Paper

For this Research Project, students will be asked to write a research paper that presents a detailed forward-thinking proposal to improve upon some aspect of the legal regulation of healthcare data, medical informatics and/or healthcare information management systems, and which will benefit medical informatics as a discipline, or improve the quality of patient care, or improve the operation of the U.S. healthcare system relating to medical data.

Students will be expected to thoroughly research and take a critical look at the following:
· Relevant history of that legal issue;
· The current state;
· Identify any evolving social/ethical mores that are driving your suggested change in the law;
· Discuss any compliance issues; and
· Most importantly, outline in detail the future state as envisioned by the student and how that state is an improvement over the current state. Among other things, consider how an existing law or regulation should be revised, or a new one enacted, or how implementation, oversight or enforcement should be changed, or compliance burden should be shifted, or whether state government should be responsible for the issue, or would the federal government be more effective, etc.

The academic goals of this student Research Project are to stimulate creative thinking about the legal, ethical and social framework that applies to healthcare data handling today; to inspire critical thinking about  accepted wisdom ; and finally, to demonstrate thought leadership regarding future legal and ethical regulation of medical informatics within the U.S. social landscape.

Students are expected to apply as much of the legal, compliance and regulatory framework, and as many of the ethical and social concerns studied in class as are relevant to the research paper.

1. Consider the legal, ethical and social issues and concerns that were presented and discussed in class or through assigned readings, and choose a topic, regulation, law, compliance situation or area that you believe needs to be changed, modified or can be improved upon, to the benefit of either medical informatics as a discipline, or to improve the quality of patient care, or to improve the operation of the U.S. healthcare system relating to medical data;

2. timely submit a paper that is about 20-35 pages, double spaced, standard margins, with a bibliography of all sources used in the Research Paper.


topic of paper


-How can insurance be used to decrease healthcare costs and increase quality of care?