New Faculty Orientation Office of the General Counsel Anne K. Garcia Senior Associate General Counsel Executive Director of Billing and Research Compliance

New Faculty Orientation Office of the General Counsel Provides legal guidance and services Saint Louis University provides coverage for: Faculty Fellows Residents Medical Students Other Staff

New Faculty Orientation Coverage is provided for all occurrences that happened during the course and scope of your employment with Saint Louis University. NOT COVERED: If injuries result from acts or omissions while under the influence of drugs or alcohol Criminal or intentional acts Outside the normal course and scope of your employment

New Faculty Orientation Failure to Cooperate with OGC or Defense Counsel Insurance: University is self insured up to $2 million Excess commercial insurance is provided up to $25 million per year.

New Faculty Orientation Reporting of Incidents Please report promptly (within 24-48 hours) Methods of Reporting 977-URPT (8778) Slucareincident.slu.edu Username: INCIDENT Password: SLUCARE1! Call the OGC at 977-5767

New Faculty Orientation Other Helpful Tips If an attorney calls, please direct them to the OGC at 977-5767. Do not speak with the attorney. If you receive a BHA or AG complaint direct it to the OGC Direct any process servers to the OGC If you are named in a lawsuit, OGC will appoint defense counsel and will notify you of your assigned counsel.

New Faculty Orientation Other Helpful Tips (Continued) Complete and Timely Documentation Limit Email Communications (Discoverable) Please discuss patient care in the appropriate setting Need assistance handling a difficult issue/family involve Risk Management

New Faculty Orientation Questions???

Office of University Compliance Physician Billing Compliance Privacy/HIPAA Research Compliance Export Controls

Billing Compliance Routine audits of billing records Education Repayments to CMS and insurance companies Sanction checks for HSC employees and vendors

Privacy/HIPAA Ensure SLU’s compliance with HIPAA privacy regulations Provide HIPAA education to SLU workforce Establish and maintain policies regarding privacy Provide incident response to issues of privacy Advise staff and management regarding privacy matters Collaborate with IT to address appropriate safeguarding of information Privacy Officer: Ron Rawson, rawsonr@slu.edu; 977-5880

Research Compliance Audits/Reviews of Research Divisions IACUC, IRB, OEHS, etc. Clinical Trial reviews Sunshine Act Research misconduct investigations Education

Reporting Saint Louis University Compliance Hotline Available and answered 24/7 Caller / reporter may remain anonymous Protection provided

the highest standards of ethical, moral, The Saint Louis University Office of University Compliance is committed to excellence in corporate integrity and responsibility. This commitment is realized through the integration of education, leadership, and service. Through collaboration the Department promotes the highest standards of ethical, moral, and lawful practices. These efforts are guided by the mission of Saint Louis University and the Jesuit tradition. Read Slide Resource! Additionally, numerous resources are available at the University to assist with questions, projects, issues and concerns. http://www.slu.edu/general-counsel-home/compliance

Questions?

Michael Reeves Export Control Officer Export Controls Michael Reeves Export Control Officer

Export Controls Federal Export Control regulations restrict the following exports: Tangible goods: technology, letters, software, or packages Communication: email and phone conversations International travel

Definitions “U.S. Person”-Any person who is a citizen of the United States, a lawful permanent resident alien of the United States, a refugee or someone here under amnesty. “Foreign National”- Any individual or organization that is not a U.S. person. “Technology Control Plan”-Plan used to manage Export Control restrictions during research project.

“Deemed Export” “Deemed Export”- Discussion with a “Foreign National” or providing them access to controlled research within the borders of the United States.

Regulated by 3 federal agencies: Department of Commerce Department of State Department of the Treasury

Department of Commerce Export Administration Regulations (EAR) 15 CFR 730-774 “Dual-use” items- commercial goods, services, and technologies that also have military or proliferation possibilities. (i.e. GPS, UAV) Maintain Commerce Control List

Department of State International Traffic in Arms Regulations (ITAR) 22 CFR 120-130 Defense items-products specifically designed for military applications (i.e. missiles) Maintain Munitions list Recently updated category XV “Defense Services” Defense services-The furnishing of assistance (including training) to foreign persons, whether in the US or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, procession or us of defense articles.

Department of the Treasury Office of Foreign Assets Control (OFAC) 31 CFR 500-599 Regulates countries, organizations, and individuals. Targets terrorists, drug traffickers, WMD proliferators, human rights violators, anti-boycott and narcotics (i.e. Marion, IL golf course, ) Maintain sanction lists for the above groups Independence Day

Export restricted and embargoed countries All three federal agencies maintain lists of restricted and embargoed countries Comprehensive Sanctioned Countries T-5 (Cuba, Iran,, N. Korea, Syria, Sudan) Most countries have commodity or information exchange specially restricted (i.e. China, Russia) China is the highest risk country for the US….most foreign national students from China. We also have students from Iraq, Iran.

Fundamental Research Exclusion Ordinarily published and shared broadly within the scientific community Generally accessible to the interested public in any form Applies only to information, not tangible goods

Educational General science, math and engineering commonly taught at schools and universities (ITAR) Information conveyed in courses listed in course catalogues and in their associated teaching labs of any academic institution (EAR)

Bona Fide Employee Is a full-time, bona fide employee; Is not a national of certain countries; Has a permanent residence in the US while employed; and Is advised in writing not to share covered technical data with foreign nationals.

Licenses Current process requires us to seek license for highest level of restriction; ITAR EAR OFAC-Travel to all T-5 and most D-1 countries

Areas of Concern for SLU Downloading software on a restricted computer Providing technology/technical data via email, fax or during a phone conversation or a meeting to a foreign national Provision of defense services to a foreign person; wherever the services take place Re-export Shadowing into restricted spaces

Travel Traveling with SLU equipment Temporary Export Certificate Clean computer Traveling with personal technology All technology is on CCL No research on personal devices while traveling

Penalties for Violations ITAR: Civil Penalties-Up to $500,000 fine ITAR: Criminal Penalties-Up to $1 million fine, up to 10 years in prison EAR: Civil Penalties-Up to $250,000 fine EAR: Criminal Penalties-Up to $1 million fine, 20 years in prison. OFAC: Civil Penalties-Up to $250,000 fine OFAC: Criminal Violations-Up to $1 million fine, 10 years in prison.

Examples of Violations Professor J. Reece Roth, University of Tennessee Guilty of 18 counts of conspiracy, fraud, and violating the Arms Export Control Act Sentenced to 48 months UT escaped fine because of cooperation and policy UM-Lowell- Failed to screen company- $100,000 fine. ITT-leading producer of night vision goggles -$100 million fine Boeing $4.2 million and $15 million fines

Contact information Michael Reeves, University Export Control Officer mreeves8@slu.edu, 977-5880

Questions?