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External Relationships and Conflicts of Interest

Philosophy/purpose

Relationships between Henry Ford Health  (HFH) and Industry can support the mission, vision, and values of HFH and its commitment to professionalism, patient care, education, research, and the communities served. However, HFH workforce must at all times maintain their primary professional commitment and responsibility to HFH. Any relationship between the HFH workforce and industry that primarily serves to promote or market industry’s products or services are prohibited under this policy.

Opportunities for professional interactions with industry also present the potential for conflicting interests. The HFH COI Policy establishes the guidelines for individuals to follow when considering external relationships, and the approval, review and reporting process. The HFH workforce is expected to be transparent with regard to all external relationships. Transparency and timely disclosure are fundamental, since not every situation can be set forth in a policy statement.

Scope

This summary incorporates HFH primary policy as well as its supplemental statement with regard to federally funded research.

All external business activities of the HFH workforce is subject to the terms of this policy. Relationships are considered in the following categories:

  • Financial Interests – ownership interests in external organizations including those that directly compete with HFH.
  • Governance - membership on governing bodies of external organizations, including those that do business with HFH or are considered competitors.
  • Financial Relationships - receiving compensation from any external organization doing business with HFH or considered to be a competitor to HFH.
  • Any other interaction with industry that may create a potential conflict.

Education

Education regarding this policy is conducted through several means. Industry receives education through the Vendor Training program, Workforce members receive education upon hiring and in periodic updates, federally funded researchers also receive targeted education prior to the receipt of funding, and no less frequently than every 4 years.

Policy

  1. Henry Ford Health Workforce must always maintain their professional commitment and responsibility to Henry Ford Health. Any relationships between the Workforce and Non-Henry Ford Health entities that primarily serves to promote, endorse, or market Non-Henry Ford Health entities’ products or services are prohibited. Opportunities exist for professional interactions and development with Non-Henry Ford Health entities that may benefit HFH and the healthcare community; however, it may also present the potential for, or the appearance of, conflicting loyalties and responsibilities for individuals within the Workforce.

  2. Henry Ford Health Workforce Members will obtain leadership approval and as applicable Human Resources approval prior to engaging in any arrangement with Non-Henry Ford Health entities including other employment. Leadership approval must be consistent with this policy, HFH Code of Conduct, the HFMG Charter and HFMG Patient Care Activities.

  3. This policy evaluates arrangements between HFH Workforce and its Family Members with Non-Henry Ford Health entities and are addressed in further detail below. Arrangements with remuneration of $5,000 or more or 33% equity ownership are considered “Significant Financial Interests”.

  4. The primary means of ensuring independence with regard to allowable financial interest is to require participants to abstain from related key decisions within Henry Ford Health.

  5. Loans from competitor organizations or Non-Henry Ford Health entities of either a personal or business nature are prohibited unless the organization is a commercial lending institution, and all terms are based on prevailing market terms.

  6. Discounted purchases of goods or services from Non-Henry Ford Health entities for personal use are only permitted if they are part of the Henry Ford Health Workforce Member discount program (Team member discounts (ehr.com)).

  7. Supply Chain Management will address matters that arise under this policy that results from interactions with contracted Henry Ford Health vendors.

Ownership Equity (Private | Public)

Henry Ford Health Workforce and their Family Members may not hold any direct or indirect financial interest in Competitor Health Care Organizations or Non-Henry Ford Health entities if such interest could in any way appear to influence the Henry Ford Health Workforce Member’s decision-making on behalf of Henry Ford Health.

  1. Investments in publicly traded organizations are allowable up to an aggregate of 5% of the outstanding equity and based on terms available to the public.
  2. Investments in privately held organizations must be evaluated based on the specific facts and circumstances.
  3. Investments in Competitor Health Care Organizations must be evaluated on a case-by-case basis.
  4. Financial interests or relationships with Non-Henry Ford Health entities when the Workforce Member or their Family Members is also the owner, investor, officer, director, trustee, or manager pose greater risk and must be managed accordingly:
    1. Comply with the Henry Ford Health Tier 1: Intellectual Property and HFHS Code of Conduct.pdf .
    2. Maintain independence between the individual’s role within Henry Ford Health and their role representing the external organization. Workforce Members cannot hold a leadership role which requires action on behalf of Henry Ford Health while being an owner or investor of a Non-Henry Ford Health Entity that is a vendor.
    3. Not utilize the individual’s role within Henry Ford Health to gain access to or influence any member of the Henry Ford Health Workforce regarding the decision to utilize the Non-Henry Ford Health entities subject product or services or to utilize Henry Ford Health services, products, facilities, technology, or intellectual property for the benefit of the Non-Henry Ford Health entities’ business.
    4. Not utilize any Henry Ford Health resources to market or sell the product or services.
    5. Disclose the interest to the Conflict-of-Interest Panel and adhere to any established management plan.

Governance | Advisory Boards

Membership on governance or advisory boards of Non-Henry Ford Health entities is allowable under the condition that the individual obtain approval from their immediate supervisor and abstain from any decisions that may appear to adversely impact the interests of Henry Ford Health or any relationship between the organization and Henry Ford Health or their patients.

  1. Membership on governing bodies of Competitor Health Care Organizations must be evaluated on a case-by-case basis and approved by the Conflict-of-Interest Panel before membership is accepted.
  2. Membership on a Henry Ford Health vendor advisory board is permissible when the participation is for providing feedback regarding the Henry Ford Health experience with the vendor. Participation shall serve as a process or experience improvement and not intended to endorse.
  3. Paid memberships are considered external consulting and are subject to the guidelines of the applicable section below.

Compensated Arrangements

  1. Financial relationships between Non-Henry Ford Health entities and Henry Ford Health Workforce or their Family Members are allowable under certain circumstances. The factors to consider in evaluating whether any financial relationship is acceptable are included but not limited to the following:

    1. As a workforce member, you must always maintain a primary professional commitment and responsibility to Henry Ford Health.
    2. Any work related to the compensated arrangement is performed on your personal time and you cannot use any Henry Ford Health logo, supplies, workforce members, equipment, or technology.
    3. Non-compensated activities that are approved based on mutual benefit to the individual and to Henry Ford Health may be conducted during work hours if approved by their supervisor.
    4. The compensated arrangement must be documented in writing and paid in accordance with fair market value. Compensation will not be an inducement or reward for referrals or prescribing patterns.
    5. You must never use your official position or influence to gain an improper advantage, economic or non-economic, for yourself or your family members, vendors, patients, customers, or associates.
    6. The work completed under this compensated arrangement is performed in your role as an individual and not on behalf of Henry Ford Health. Henry Ford Health assumes no liability for the work you complete under this compensated arrangement.
    7. Independent consulting guidance will not be promotional in nature. It will focus on quality, best practices, and disease state.
    8. Locations must be appropriate for the business being conducted.

  2. Financial arrangements between Workforce Members and Non-Henry Ford Health entities that do not meet this may not be accepted.

  3. Below are illustrative compensated arrangements:

    1. Education.
      1. Workforce Members conducting education is acceptable to the extent the education meets ACGME standards and the activity is in support of a non-profit or educational organization (e.g., medical schools, grand rounds, invited lecturer for a specialty association, etc.)
      2. Workforce members may not personally accept remuneration from external sources for conducting education at any Henry Ford Health location or Henry Ford Health sponsored activity.
    2. Speaking Arrangements.
      1. The purpose of any speaking arrangement will be for educating the medical community regardless of whether continuing medical education credits are awarded. The content will not be misleading or bias towards the company’s product. Any results presented must meet academic research standards and not singularly focus on Non-Henry Ford Health entities sponsor’s product(s). Promotional activities outlined within this policy are not intended to meet the Food and Drug Administration’s regulatory definition. The presentation will have full disclosures regarding your compensated arrangement with the company. Your speaking will not be a part of sales or marketing.
    3. Honoraria:
      1. Honoraria is similar to consulting fees, however, is generally reserved for a brief, one-time activity. Another distinction is that honoraria are generally provided for services without a set price.
      2. Payments for an activity that occurs more than once and are considered to be educational but not meeting the above criteria are considered as “external consulting” under this policy.
    4. External consulting:
      1. Acceptable categories include a broad range of advisory and personal service relationships including compensated Board positions and consulting agreements with Non-Henry Ford Health entities.
      2. Individual business unit policies specify additional criteria with regard to acceptable external consulting and must be considered in conjunction with this policy.
    5. Expert Testimony:
      1. Workforce members may provide expert medical legal testimony as long as Henry Ford Health is not a named party to the litigation or in any known way stands to be adversely impacted by the outcome of the litigation.
      2. In the event that any Workforce Member (including physicians or other medical staff) is required by law or by other applicable ethical standards to give testimony, expert or otherwise, and the expected testimony is potentially adverse to Henry Ford Health, the affected workforce member should consult with the Office of General Counsel (Legal) and/or Corporate Compliance prior to giving said testimony. Henry Ford Medical Group should refer to Tier 2: Medical Legal Testimony.

Non-Henry Ford Health entities Funded Travel

  1. Travel or lodging costs must not be paid for by Non-Henry Ford Health entities unless they fulfill a bona-fide educational, research, or consultative purpose and must directly benefit Henry Ford Health. All travel should follow the Henry Ford Health Tier 1: Travel and Expense Policy.
  2. Non-Henry Ford Health entities funded travel must never be accepted for a family member of a Henry Ford Health Workforce Member.

Intellectual Property

Henry Ford Health Workforce Members who obtain intellectual property rights by making, conceiving, developing, contributing to, improving, or deriving a device or process because of the individual’s contract, employment, appointment, or other relationship with Henry Ford Health can pose a potential risk. Henry Ford Health Workforce Members shall follow the Henry Ford Health Tier 1: Intellectual Property with respect to such assets.

Henry Ford Health Workforce Members should disclose any intellectual property rights in which they are involved. Review will be based on whether they:

  1. Accept compensation for intellectual property without complying with the Tier 1: Intellectual Property policy.
  2. Have an intellectual property right and participate in a principal role with ongoing research that potentially impacts the value of the intellectual property right.
  3. Have an intellectual property right on which your department is conducting research and has appointed you a principal investigator, thus indirectly involving you.
  4. Participate in a situation in which you develop intellectual property and disclose this to Henry Ford Health; Henry Ford Health waives rights to you; you maintain patent costs and seek research support from manufacturers; a manufacturer enters into a contract with Henry Ford Health for you to do research on patients in the areas of your intellectual property.

The following criteria must be followed when Henry Ford Health Workforce Members have outside intellectual property rights:

  1. When acting on behalf of your external interests/product you will:
    1. Refrain from the usage of any Henry Ford Health assets or logos.
    2. Avoid reference to your specific roles at Henry Ford Health.
    3. Not utilize any items or locations that are linked to Henry Ford Health.
    4. Not in any way allow the implication that your external interest/product are in any way connected to Henry Ford Health, through you or otherwise.
  2. When acting on behalf of Henry Ford Health you will refrain from marketing the external interest/product.
  3. If you would like to broker a relationship between the external interest/product with Henry Ford Health, you must contact the Henry Ford Innovation Institute.
  4. If your third-party distributor for your external interest/product does any type of business transaction with Henry Ford Health (any entity) you will not be involved with any of the discussions on behalf of them or Henry Ford Health.

Transactions with HFH | HAP

Henry Ford Health Workforce Members shall not enter into any transaction with Henry Ford Health where there is potential for the Workforce Member to gain advantage by virtue of their status at Henry Ford Health. A transaction should be disclosed for any of the following situations:

  1. Sale, exchange or leasing of property.
  2. Lending of money or other extension of credit.
  3. Furnishing of goods, services, or facilities.
  4. Payment/reimbursement of expenses other than qualified Workforce Member wages/expenses.

Other Interactions Creating Risks for Conflict

  1. Philanthropic Activities:
    1. As a charitable organization, Henry Ford Health may occasionally solicit and accept donations from Non-Henry Ford Health entities in support of one or more philanthropic activities benefiting one or more programs of Henry Ford Health.
    2. All solicitation of Non-Henry Ford Health entities for sponsorship, CME activities, departmental activities, supplies, functions, events, fundraisers must be conducted by Henry Ford Health Development Office to ensure that the philanthropic support is unrelated to any business relationship. Business discussion and philanthropic activities must be separate. Workforce Members who have relationships with Non-Henry Ford Health entities must recuse themselves from any business or contract negotiations.
    3. Members of the Workforce may accept invitations to be the guest of the sponsor at a philanthropic activity subject to the following criteria:
      1. Such invitations should be infrequent, and representatives of the sponsor must also be in attendance; otherwise, the invitation constitutes a gift.
      2. Acceptance of the invitation shall be disclosed through the Henry Ford Health conflict-of-interest disclosure process.
      3. No contractual arrangements between Henry Ford Health and the sponsor may be currently under negotiation or anticipated to be under negotiation within a six-month period.
    4. Support for Continuing Medical Education (CME) is acceptable and must be conducted by the Henry Ford Health Development Office. Such support must follow all ACGME accreditation criteria including the Standards for Commercial Support and must be disclosed to the participants prior to the start of the activity.
  2. Non-Henry Ford Entity Funding: All payments received from Non-Henry Ford Entities must be for a bona-fide business purpose documented in writing and shall not be for the purposes of access. All philanthropic payments must be sent to the Development Office who will receive, record, deposit to the appropriate account, and acknowledge the donation.
  3. Business | Educational Meetings:
    1. The primary purpose of all business meetings between Workforce and Non-Henry Ford Health entities must serve a legitimate business purpose and be held at a Henry Ford Health facility.
    2. When such meetings need to be held off-site, the meeting may include food under the following circumstances:
      1. The choice of location serves to promote the overall business purpose of this meeting and any food provided is appropriate and reasonable.
      2. Only those individuals necessary to conduct the business purpose of the meeting should be in attendance.
      3. Such off-site meetings should be infrequent.
    3. Invitations from Non-Henry Ford Health entities to attend activities that are predominantly of a social or entertainment nature may be accepted for Henry Ford Health sponsored events or only if the actual fair market value associated with participation is personally paid by the Workforce Member.
  4. Gifts: No gifts, of any type or amount, may be accepted by the Henry Ford Health Workforce from Non-Henry Ford Health entities. This includes, but is not limited to, companies currently engaged in or under consideration to do business with Henry Ford Health.
    1. No vendor promotional items (pens, penlights, paper pads featuring product names) of any kind are permitted within Henry Ford Health.
    2. No food of any kind will be directly supplied by vendors for Workforce Members at any Henry Ford Health location. See Tier 1: Vendor Policy and Procedure.
  5. Unrestricted grants:
    1. Non-Henry Ford Health entities funding of educational activities and research (including scholarships and fellowships) must be arranged through the Chair, Vice President of Medical Education or Vice President of Research as appropriate, and payments must be made through the Development Office to ensure appropriate receipting, recording, depositing, and acknowledging. Non-Henry Ford Health entities funding of activities and research where a license or other rights to Henry Ford Health technology, knowledge or intellectual property is contemplated being granted to the sponsor should be processed through the Vice President and Chief Innovation Officer.
    2. Any type of meetings funded by the unrestricted grant must not include presentations by Non-Henry Ford Health entities, and Non-Henry Ford Health entities must not select the speakers or content of any presentation.
    3. Funding of the cost of Henry Ford Health Workforce attending lectures or conferences supported by an unrestricted grant is allowable.
  6. Political Contribution and Lobbying:
    1. Henry Ford Health Workforce Members may enjoy membership in and contribute to political parties, trade associations and similar organizations. However, any political and related activity is strictly on the Workforce Member’s own time and expense and shall not be done in the name of or with the appearance of support by Henry Ford Health without express prior written approval.
    2. No Henry Ford Health resources may be used to induce action or bribe any public official, government employee, agency, or other organization either for the benefit of Henry Ford Health or the individual Workforce Member. Any efforts to influence legislation must comply with all applicable local, state, and/or federal laws and policies.
    3. Gifts received from or purchased from governmental officials are prohibited. Henry Ford Health Workforce Members may not accept or solicit gifts from governmental officials or their agents.

Conflict of Commitment (COC)

Relationships between Henry Ford Health (HFH) and Industry can support the mission, vision, and values of HFH and its commitment to professionalism, patient care, education, research, and the communities served. However, HFH workforce must at all times maintain their primary professional commitment and responsibility to HFH. Any relationship between the HFH workforce and industry that primarily serves to promote or market industry’s products or services are prohibited under this policy.

  1. Workforce members are encouraged to engage in outside activities to the extent that they have approval from their supervisor/chair/division head. However, any such activities must be clearly related to the expertise of the Workforce Member and must not create an unmanageable conflict.
  2. The proportion of a full-time Workforce Member’s professional effort devoted to compensated outside activities is not to exceed forty (40) hours a month. Not to exceed more than 480 hours in a calendar year.
  3. Non-compensated outside activities during off-hours are not subject to time limitations; however, to ensure a conflict does not exist, the outside activities are still subject to prior approval and disclosure requirements.

Disclosure and review requirements

The Audit and Compliance Committee of the HFH Board of Trustees has delegated responsibility for this policy to the HFH Chief Compliance Officer, who has established a Conflict-of-Interest Review Panel (COI Panel - Institutional Body). Certain job categories within HFH, including those individuals with significant research roles are required to make regular and no less frequent than annual disclosures of relationships creating the potential for conflict of interest. All PHS funded researchers are responsible to update these disclosures with any significant changes.

The COI Panel oversees the review of all disclosure statements. With regard to federally funded researchers, all external relationships are presumed to be “related.” The COI Panel will ascertain if the external relationship creates a financial conflict of interest (FCOI) based upon its review of disclosed information, the structure of the research protocol and interviews with the involved researcher. When necessary, the COI Panel will collaborate with the researcher, the Office of Research Administration, and other appropriate parties to establish a Management Plan (PHS funded research requires a Federal Management Plan” FMP”).

All FMPs shall be reported to appropriate PHS officials prior to the expenditure of any funds, within 60 days of identification of any qualified person newly participating in the research and within 60 days of any newly identified FCOI’s.

Sub-recipients shall provide certification of independent compliance with the regulations, including copies of any related FMP or shall agree to comply with the applicable HFHS policies and procedures.

The discovery of new factors or relationships may require a retrospective review. Such reviews will be completed no more than 120 days after identification of an event of non-compliance and should a FMP be necessary, the FCOI will be disclosed in all public presentations regarding the research as well as an addendum to any previously published information. The COI Panel shall also promptly notify the appropriate PHS official in the event of the determination of bias in any PHS funded research or any failure to comply with an FMP.

Maintenance of records

Minutes of the COI Panel shall document processes followed in evaluating all disclosure statements including those related to research programs and all such records and any resulting FMPs shall be maintained for no less than 3 years.

Enforcement and remedies

All members of the workforce agree to comply with all elements of the policy on External Relationships. Failure to comply will result in progressive discipline as outlined in HFH Human Resource Policies and as appropriate, evaluation under the HFH policy on research misconduct.

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