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The Genetics Hotline: Responsibility and Liability When Handling Unsolicited Patient Communications
Wednesday, May 20, 2020

2:00 pm – 3:30 pm ET

www.acmgeducation.net

The session begins with case vignettes, then brief presentations by speakers and follow with a moderated discussion. The cases illustrate the positions in which clinicians, diagnosticians and researchers, find themselves in the era of increased knowledge-sharing and online engagement directly with patients and families. And in practice today, many patients are getting much of their genetics/health information outside of their clinicians' offices in Facebook, Twitter and other online forums, some forming their own online forums for knowledge-sharing and research. Many of the Facebook closed patient groups only contain patients but others count among their members medical geneticists, clinical specialists, surgeons, and genetic counselors. These professionals make up a tiny fraction of the total membership, yet their participation, however limited, is incredibly valuable to the community. In a recent survey as part of a Robert Wood Johnson Foundation grant, participants indicated that one of the main factors that would improve their online group experience was more professional participation. Patients and families are not getting enough information in their brief interactions with their clinicians, and they are going online to these closed groups to find it.

The cases raise several concerns: for example, which state or country's laws will apply when the person sending an email and the person responding to it are in different states/countries? For a clinician, a major question is whether responding to an email or answering a question in an online forum might give rise to a physician-patient relationship, which in turn might lead to medical malpractice liability. Non-clinicians may be liable under a general negligence theory and need to be concerned about whether responding to an inquiry might be perceived as "practice of medicine," which might subject them to sanctions for the unauthorized practice of medicine. Clinician-researchers may be liable under a malpractice or negligence theory, depending on the circumstances. There are various legal risks in communicating with people and responding to their queries. These risks can unquestionably be reduced if one handles the communications carefully, making appropriate disclaimers and disclosures. Physicians and geneticists often tend to overestimate the risks of being sued or fail to realize that there are a lot of things one can do to reduce lawsuit risks. Experts may ask the question whether it is worth it: responding to emails is, in most cases, an uncompensated activity and it is one that can consume a lot of time. If it involves any legal risk, a lot of people decide it's just not worth getting involved. That is understandable, yet it is a shame, because it takes the most knowledgeable people out of the conversation and leaves patients without access to information that could be helpful and useful.

So how do we balance effective support for patients yet protection for professionals from liability? This session will tackle tough questions and provide guidance to the community for how to handle these situations.

Target Audience

All healthcare professionals interested in the diagnosis, management, treatment and prevention of genetic conditions and increasing their understanding of the genetic basis of common, chronic health problems affecting both children and adults will find the programming applicable to their practice.

Agenda

Learning Objectives

At the conclusion of this session, participants should be able to:

1. Recognize common environments and situations under which unsolicited patient contact may occur
2. Review examples of how physicians have handled unsolicited patient contact
3. Define the responsibilities that experts have for sharing knowledge and information
4. Define the liabilities at play for experts (clinical and non-clinician) for providing information to patients in response to email or in an online forum
5. Discern how to optimize learning and reduce risk when engaging in online dialogue
6. Distinguish between medical advice and medical information
7. Identify communication strategies to clarify the limits of one’s responsibilities, promote positive patient outcomes, and avoid liability
8. Examine the reasons variants are reinterpreted over time and what responsibilities labs, clinicians and patients play in receiving updates to variant classifications
9. Appropriately support patient-initiated re-contact when variant classifications change over time

Presenters

Heidi L. Rehm, PhD

Chief Genomics Officer in the Department of Medicine, Center for Genomic Medicine at Massachusetts General Hospital (MGH)

Susan M. Wolf, JD.

McKnight Presidential Professor of Law, Medicine & Public Policy Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota

Barbara J. Evans, PhD, JD, LLM

Mary Ann & Lawrence E. Faust Professor of Law and Director of the Center for Biotechnology & Law at the University of Houston Law Center

Adrian Thorogood, BA&Sc, BCL/LLB, LLM

Associate at the Centre of Genomics and Policy (CGP) at McGill University in Montreal, Canada

Jill V. Holdren, MA

Co-founder, The Light Collective, Boulder, CO

Wendy K. Chung, MD, PhD, FACMG

Clinical and molecular geneticist and the Kennedy Family Professor of Pediatrics and Medicine,

Columbia University

Financial Disclosures

Disclosure Statement

It is the policy of the American College of Medical Genetics and Genomics to plan and implement all of its educational activities in accordance with the ACCME Essentials and Areas and ACCME® Policies to ensure balance, independence, objectivity and scientific rigor. In accordance with the ACCME® Standards for Commercial Support, everyone (speakers, moderators, committee members and staff) who is in a position to control the content of an educational activity certified for AMA PRA Category 1 Credit™ is required to disclose all financial relationships with any commercial interests (see definition below) within the past 12 months that creates a real or apparent conflict of interest. Disclosure must include financial relationships of the individual and those of their spouse/partner. Individuals who do not disclose will be disqualified from participating in a CME activity.

This disclosure pertains to relationships with ACCME-defined commercial interests whose products or services may be related to the subject matter of the presentation topic. Any real or apparent conflicts of interest related to the content of the presentations must be managed prior to the educational activity. ACMG will identify, review and resolve all conflicts of interests prior to an educational activity being delivered to learners.

NOTE:

• ACMG will follow the ACCME’s expectation that no employees or owners of commercial interests will be involved as planners/faculty/presenters of a CME accredited activity.
• The ACCME definition of a commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
• The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.
• Diagnostic laboratories are not considered commercial interests unless they are owned by or have a sister organization which is a commercial interest.

Heidi L. Rehm, PhD

Has no relevant financial relationships to disclose.

Susan M. Wolf, JD.

Has no relevant financial relationships to disclose.

Barbara J. Evans, PhD, JD, LLM

Has no relevant financial relationships to disclose.

Adrian Thorogood, BA&Sc, BCL/LLB, LLM

Has no relevant financial relationships to disclose.

Jill V. Holdren, MA

Has no relevant financial relationships to disclose.

Wendy K. Chung, MD, PhD, FACMG

Dr. Chung has disclosed that she is a consultant/advisory board for Regeneron Genetics Center.

Moderator disclosures:

Heidi L. Rehm, PhD

Has no relevant financial relationships to disclose.

Educational Credit

Accreditation Statement

The American College of Medical Genetics and Genomics is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Designation Statement

The American College of Medical Genetics and Genomics designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CE (Continuing Education for non-physicians): This activity has been approved for CE credits.
*The certificate is accepted by the ABMGG for certification.

Genetic Counselor Credit

The National Society of Genetic Counselors (NSGC) has authorized American College of Medical Genetics to offer up to 1.5 Category 1 contact hours for this activity. The American Board of Genetic Counseling (ABGC) will accept CEUs earned at this program for the purposes of genetic counselor certification and recertification.

ACMG will report completed accredited sessions to NSGC for credit certificates on December 4, 2020, December 3, 2021 and July 8, 2022. Submissions outside of these parameters may incur a processing fee of $35.

P.A.C.E.® CEUs- Laboratory Directors and Laboratory Personnel

ACMG is approved as a provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education (P.A.C.E.®) Program. The American College of Medical Genetics and Genomics designates this OnDemand course for a maximum of 1.5 contact hours. ACMG is approved by the Florida Board of Clinical Laboratory Personnel as CE Provider #50-11878. This course is registered # 20-775394 with CEBroker.  ACMG is approved by the California Department of Health Services through the ASCLS P.A.C.E.®

Claiming your Educational Credits

Complete the activity and carefully complete the evaluation form. Deadline to claim educational credits is within 30 days from the date of the webinar. ACMG will not accept any credit requests for live meetings after that period.

HIPAA Compliance

The ACMG supports medical information privacy.  While the ACMG is not a “covered entity” under HIPAA 1996 and therefore is not required to meet these standards, ACMG wishes to take reasonable steps to ensure that the presentation of individually identifiable health information at ACMG-sponsored events has been properly authorized.  All presenters have completed a form indicating whether they intend to present any form of individually identifiable healthcare information.  If so, they were asked either to attest that a HIPAA-compliant consent form is on file at their institution, or to send ACMG a copy of the ACMG HIPAA compliance form. This information is on record at the ACMG Administrative Office and will be made available on request.

Content Validation

ACMG follows the ACCME policy on Content Validation for CME activities, which requires:

Content Validation and Fair Balance

1. ACMG follows the ACCME policy on Content Validation for CME activities, which requires:

1. All recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
2. All scientific research referred to, reported or used in CME in support or justification of patient care recommendations must conform to the generally accepted standards of experimental design, data collection and analysis.

2. Activities that fall outside the definition of CME/CE; “Educational activities that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession” (source: ACCME and AMA) will not be certified for credit. CME activities that promote recommendations, treatment, or manners of practicing medicine or pharmacy that are not within the definition of CME/CE or, are known to have risks or dangers that outweigh the benefits or, are known to be ineffective in the treatment of patients.
3. Presentations and CME/CE activity materials must give a balanced view of therapeutic options; use of generic names will contribute to this impartiality.  If the CME/CE educational materials or content includes trade names, where available, trade names from several companies must be used.

Off-label Uses of Products

When an off-label use of a product, or an investigational use not yet approved for any purpose, is discussed during an educational activity, the accredited sponsor shall require the speaker to disclose that the product is not labeled for the use under discussion, or that the product is still investigational. Discussions of such uses shall focus on those uses that have been subject of objective investigation.

Disclaimer

The ACMG does not endorse, or recommend the use of this educational program to make patient diagnoses, particular by individuals not trained in medical genetics. Adherence to the information provided in these programs does not necessarily ensure a successful diagnostic outcome. The program should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed at obtaining the same results. In determining the propriety of any specific procedure or test, a healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen.