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Twenty-First Century Cures Act Final Rule and Adolescent Health Care: Leadership Education in Adolescent Health (LEAH) Program Experiences

      Expectations regarding the sharing of electronic health information (EHI) are rapidly evolving in the U.S. The Office of the National Coordinator for Health Information Technology is responsible for implementation of key provisions of the 21st Century Cures Act Final Rule [
      The Office of the National Coordinator for Health Information Technology
      ONC's cures act final rule.
      ]. These provisions are designed to support the access, exchange, and the use of EHI; address occurrences of information blocking; and support patients' access to their EHI in a form convenient for them. Health-care institutions have been rapidly developing systems to meet expectations of the Final Rule under the threat of substantial financial penalties. The Final Rule generally assumes that patients are legal adults, placing institutions and professionals who provide health care to adolescents in a particularly complex situation [
      • Kressly S.J.
      • Webber E.C.
      Pediatricians’ need for specific EHR functionality finally recognized.
      ,
      • Pageler N.M.
      • Webber E.C.
      • Lund D.P.
      Implications of the 21st century cures act in pediatrics.
      ,
      • Goldstein R.L.
      • Anoshiravani A.
      • Svetaz M.V.
      • Carlson J.L.
      Providers' perspectives on adolescent confidentiality and the electronic health record: A state of transition.
      ,
      • Schapiro N.A.
      • Mihaly L.K.
      The 21st century cures act and challenges to adolescent confidentiality.
      ,
      • Bourgeois F.C.
      • DesRoches C.M.
      • Bell S.K.
      Ethical challenges raised by OpenNotes for pediatric and adolescent patients.
      ].
      A long-standing framework of legal, ethical, and professional guidelines support nuanced decision-making about information-sharing between health-care professionals, adolescents younger than 18 years (minors), and their parents or legal guardians [
      Center for Adolescent Health & the Law
      Consent and confidentiality protection.
      ,
      American Medical Association Council on Scientific Affairs
      Confidential health services for adolescents.
      ,
      • Maslyanskaya S.
      • Alderman E.M.
      Confidentiality and consent in the care of the adolescent patient.
      ,
      • English A.
      Adolescent & young adults health care in Minnesota: A guide to understanding consent & confidentiality laws.
      ,
      Guttmacher Institute
      An overview of consent to reproductive health services by young people.
      ]. Information regarding routine health care is typically shared with both minors and their parents, and developmentally appropriate parent-teen communication is encouraged [
      ]. To increase the chance that adolescents receive needed health care for sensitive health issues related to sexual behaviors, substance use, and mental health, all 50 states and the District of Columbia have laws that allow most minors to request and receive at least some sensitive health services based on their own consent [
      • English A.
      • Bass L.
      • Dame-Boyle A.
      • Eshragh F.
      State minor consent laws: A summary.
      ,
      Guttmacher Institute
      Minors’ access to contraceptive services.
      ]. These laws also often provide confidentiality protection and allow minors some control over the release of their health information related to the services for which they give consent. Other laws that support confidential adolescent health care include the Health Insurance Portability and Accountability Act Privacy Rule, the regulations for the federal Title X Family Planning Program, federal regulations for substance use disorder programs, and other federal laws [
      Center for Adolescent Health & the Law
      Consent and confidentiality protection.
      ,
      • English A.
      Adolescent confidentiality protections in title X.
      ,
      • English A.
      • Ford C.A.
      The HIPAA privacy rule and adolescents: Legal questions and clinical challenges.
      ]. Taken together, the intent of this framework is to ensure that all adolescents receive high-quality health care that leads to improved health outcomes. This framework recognizes the fundamental importance of developmentally appropriate involvement of parents in adolescent health care and providing confidential care regarding sensitive health issues when needed. It is important to recognize that some adolescents will only seek health care and communicate with clinicians regarding sensitive health issues if that health care is provided confidentially [
      • Ford C.A.
      • Bearman P.S.
      • Moody J.
      Foregone health care among adolescents.
      ,
      • Ford C.
      • Millstein S.
      • Halpern-Felsher B.
      • Irwin C.
      Influence of physician confidentiality assurances on adolescents' willingness to disclose information and seek future health care.
      ]. It is important to understand how institutions can support provision of adolescent health care that aligns with this framework, while also complying with the requirements of the Final Rule.
      On May 10, 2021, leaders from the seven Leadership Education in Adolescent Health (LEAH) Programs convened to discuss their institutions' strategies to meet expectations of the 21st Century Cures Act Final Rule. The LEAH Programs are nationally recognized for their excellence in providing adolescent and young adult health care and training future multidisciplinary leaders. Representatives from the LEAH Programs at the following medical centers participated: University of Alabama at Birmingham School of Medicine; Harvard Medical School/Boston Children's Hospital; University of Pennsylvania Perelman School of Medicine/Children's Hospital of Philadelphia; University of California at San Francisco/Benioff Children's Hospitals; University of Washington/Seattle Children's Hospital; University of Southern California/Children's Hospital of Los Angeles; and University of Minnesota/Fairview Health System. The main areas of the discussion are described in the following sections.

      Electronic Note Sharing

      The Cures Act “Information Blocking” rules, and their requirement to provide immediate access to EHI in response to patient requests, have resulted in widespread interest in automatic electronic note sharing from all clinical encounters with patients, often referred to as “Open Notes.” Pragmatically, this means that physicians, nurses, social workers, and other health-care professionals automatically share clinical visit notes with patients seen in all clinical settings (e.g., outpatient, inpatient, emergency room settings). Representatives reported that their home institutions were in different stages of electronic note sharing with patients and parents, with variation by clinical settings. One institution reported they have been electronically sharing notes since 2014, and all other institutions reported more recent experiences. Representatives from all institutions reported active discussions about the complexities of sharing adolescent EHI.
      All representatives reported that discussions about information-sharing among health-care professionals, minors, and their parents have influenced institutional guidelines on adolescent EHI release. All reported that limitations in the capabilities and flexibility of specific electronic health record (EHR) systems, EHR vendor support, and institutional EHR/EHI support have influenced guidelines. Strategies chosen for EHI release guidelines varied widely. Most reported variation in strategies for sharing notes based on type of clinical settings. For example, some institutions were preventing release of all notes from specific clinical sites when confidential health information is contained in most notes (e.g., behavioral health, family planning, adolescent medicine subspecialty clinics), while other institutions were working toward automatic or manual release of EHI from these clinics linked to reliable control over who would receive EHI. Strategies varied for release of EHI from other health-care settings (e.g., primary care, specialty care, emergency rooms, inpatient settings) where notes contain both routine health information and embedded confidential health information collected during recommended psychosocial screening/past medical histories (e.g., sexual history, contraceptive use, substance use, mental health). Strategies included: system control of release of notes based on adolescent age; clinician control of electronic release of entire clinical encounter notes with decisions based on note content, patients' capacity to consent to confidential care available within the context of state legal frameworks, and patients' request; and segmenting confidential information in the EHR linked to the ability to prevent release of confidential information to parents unless permission is granted by the adolescent patient. Educational needs of all professionals caring for adolescent patients in all settings were discussed, as many are not prepared to manage sensitive health information in a confidential patient-centered manner.

      Release of Medication Lists, Laboratory Test Results, and Radiology Reports

      Sharing information about medications, test results, and radiology reports related to sensitive services with parents or others without the adolescent's permission, even if unintentionally released, results in the loss of confidentiality. Legal, ethical, and professional guidelines often support allowing adolescents to control release of information about sensitive health services to which they have provided consent. Technical challenges related to segregating EHI about medications, tests, and radiology studies provided as part of confidential adolescent health care from full EHRs were discussed, and wide variations in strategies designed to minimize risks of unintentional disclosure were reported, including: preventing the release of all medication lists, test results, radiology reports in the adolescent age group; release of all information to adolescents but not to parents; creating systems that supported clinician tailoring of release of information based on the specific clinical scenario; and system-level tailoring which prevents release of certain medications, test results, and/or radiology reports usually (but not always) related to confidential health services. There was also variability among the institutions in what constitutes timely release, with some reporting no delay for any results, and others with longer delays for results.

      Directing EHI to Adolescent Patients Versus Parents (Proxy Systems)

      Tailoring the release of EHI from the EHR in a way that information can be differentially directed to the minor patient (via patient portals) or parents and guardians (via parent portals) often involves creating what is referred to as “proxy systems.” Representatives from all institutions described the development of proxy systems. When patients turned 12 or 13 years of age, systems automatically gave adolescent patients and their parents different access to EHI through portals. However, representatives reported wide variability in the content of EHI available to adolescent patients and parents. Examples included: adolescents automatically received their own account with full access to their entire EHR, some contingent and some not contingent upon parent approval; tailoring of information that would be visible in adolescent patient versus parent portals; and limiting parental access to adolescent EHI. The level of confidence that proxy systems work as intended also varied, which influenced choices about system design. Higher levels of confidence were associated with systems designed to prevent release of all confidential information to both adolescents and parents, typically using segmented EHRs available in all clinical settings. Lower levels of confidence were associated with systems designed to enable release of confidential adolescent health information directly to minors through a patient portal, with concerns that parents could access their adolescent's portal without permission, resulting in unintended sharing of confidential information.

      EHI Sharing Among Older Adolescent Populations

      When older adolescent patients become legal adults, which is 18 years of age in most states, all institutions reported a general strategy of removing parental access to the EHR. In this situation, adolescents who become legal adults will gain immediate full EHR access to all past, current, and future EHI. For older adolescents with significant intellectual/cognitive disability, provisions for ongoing parental access to medical records are made within the context of legal guardianship. Older adolescents with (or without) special health-care needs who have the capacity to provide informed consent may choose to grant parental access to their health records. It appears that this choice is typically limited to granting parents full access to an EHR, without specific protections for confidential information.

      Discussion

      Increased sharing of EHI among adolescent patient populations can lead to opportunities to improve adolescent health care and health outcomes if placed within a developmental context. Our discussion revealed that all seven institutions are currently seeking to create EHI-sharing systems consistent with high-quality adolescent health care that meets the needs of both adolescent patients and their parents or guardians. Importantly, no EHI system was able to fully support sharing EHI with both patients and parents in a way that supports parent-adolescent communication and collaboration about routine health care, while also simultaneously supporting patient access to and control over confidential EHI for sensitive health issues.
      Institutions are facing technical limitations of currently available EHI/EHR systems as they struggle to meet expectations of the Final Rule in a way that minimizes risks of disclosing legally protected confidential sensitive adolescent health information to parents. As a result, institutions and clinicans are often forced to decide between varying strategies that either compromise parental access to EHI for routine adolescent health care, limit adolescent patients' access to EHI regarding their own confidential health care, or both. This variability was noted for sharing EHI regarding notes, medications, laboratory results, and radiology reports. Concerns about reliability of proxy systems are being confirmed [
      • Xie J.
      • McPherson T.
      • Powell A.
      • et al.
      Ensuring adolescent patient portal confidentiality in the age of the cures act final rule.
      ]; this issue is limiting health professionals' confidence in whether the released EHI containing confidential information will exclusively reach the person to whom it is intended (e.g., patient, parent, or both). Many health-care professionals have unmet educational needs related to guidelines for providing confidential adolescent health care and how their institution's EHI/EHR system is set up to try to meet the needs of this patient population.
      The unique needs of adolescent patients and their families within the context of EHRs have previously been described [
      • Anoshiravani A.
      • Gaskin G.L.
      • Groshek M.R.
      • et al.
      Special requirements for electronic medical records in adolescent medicine.
      ,
      • Ancker J.S.
      • Sharko M.
      • Hong M.
      • et al.
      Should parents see their teen's medical record? Asking about the effect on adolescent-doctor communication changes attitudes.
      ,
      • Stablein T.
      • Loud K.J.
      • DiCapua C.
      • Anthony D.L.
      The catch to confidentiality: The use of electronic health records in adolescent health care.
      ]. Expectations of the Cures Act Final Rule have placed a spotlight on the challenges of designing EHI mechanisms with currently available EHR systems that meet the needs of high-quality adolescent health care [
      • Bourgeois F.C.
      • DesRoches C.M.
      • Bell S.K.
      Ethical challenges raised by OpenNotes for pediatric and adolescent patients.
      ]. Although our experiences are limited to seven leading academic institutions, the variability in reported approaches is striking. This variability is combined with common difficulties shared by each institution in designing an EHI-sharing system that appropriately includes parents in routine health care, protects confidential adolescent information, and shares information (including confidential information when appropriate) with adolescents, parents, or both in a developmentally sensitive way. We suspect that this reflects the widespread challenges faced by clinicians, practices, and health systems providing adolescent health care across the country.
      National organizations have recognized this extraordinarily challenging situation. The Society for Adolescent Health and Medicine, North American Society for Pediatric and Adolescent Gynecology, and The American Academy of Pediatrics (AAP) have all published recommendations and guiding principles that we strongly support [
      • Carlson J.
      • Goldstein R.
      • Hoover K.
      • Tyson N.
      NASPAG/SAHM statement: The 21st century cures act and adolescent confidentiality.
      ,
      American Academy of Pediatrics
      Guiding principles for information sharing and blocking in pediatric care.
      ]. Adolescent health-care professionals can play a number of important roles including: serving as a leader in providing institutional and care provider education regarding confidentiality rights for minors in your state; meeting with the health informatics team and legal counsel at your institution to understand their plan to ensure adolescent confidentiality, as well as to ensure compliance with state and federal laws (e.g., 21st Century Cures Act Final Rule, Health Insurance Portability and Accountability Act Privacy and Security Rules); advocating for information access and record release policies that incorporate adolescent confidentiality protections; considering separate and differential portal account access for the adolescent minor and proxy; advocating for a confidential note type or ability to designate notes as confidential to allow segmented access to health information within the EHR; and creating educational materials for patients and families about adolescent confidentiality and information access within the EHR [
      • Carlson J.
      • Goldstein R.
      • Hoover K.
      • Tyson N.
      NASPAG/SAHM statement: The 21st century cures act and adolescent confidentiality.
      ]. Educational materials for interdisciplinary health-care professionals who may not be familiar with rights of adolescents to confidential health care will also be needed.
      Given the complexity of the 21st Century Cures Act Final Rule, it is helpful to focus on clarification of actual requirements. On July 23, 2021, AAP published a pragmatic summary of their interpretation of the 21st Century Cures Act Interoperability Final Rule to provide guidance and facilitate understanding of current requirements for sharing of EHI [
      American Academy of Pediatrics
      What pediatricians need to know about the 21st century cures act interoperability final rule.
      ]. This document also provides a link to AAP Cures Act Experts, which can be used for ongoing communication as Final Rule requirements evolve. The following pertinent key points are discussed in the July 23rd document:
      • At this time, practices and health systems are not required to implement a patient portal.
      • The Final Rule mandates EHI to be shared upon request. Many practices, hospitals, and health systems are choosing to implement a proactive push of the covered EHI. The rule itself does not mandate proactive pushing of EHI to the patient portal or proactive sharing by other means. Responses to requests for EHI need to be timely.
      • The Final Rule does not make any changes to who has the right to access EHI. The Final Rule makes changes to how EHI is shared; it does not impact with whom the EHI can be shared.
      • As of June 2021, there are no established enforcement rules or disincentives (i.e., fines) for information blocking by clinicians, practices, and health systems that do not run health information networks/health information exchanges. Enforcement rules for these stakeholders will be established in a federal rule-making process, including a standard public comment period, in the future.
      At the same time, AAP published guiding principles to be used when a clinician, practice, or health system is determining how to respond to a request for EHI from a patient or parent/guardian [
      American Academy of Pediatrics
      Guiding principles for information sharing and blocking in pediatric care.
      ]. The following pertinent key points are included in this AAP report:
      • Pediatricians and health systems should take a prosharing approach, making appropriate access to EHI for patients, parents, and guardians as easy as possible.
      • All EHI has the potential to be sensitive, depending on context. The AAP supports allowing pediatricians and other clinicians who provide health care for children and adolescents, and who are stewards of EHI for those patients, to be granted discretion and latitude to withhold EHI when they are concerned about the impact/consequences for the child.
      • For many pediatricians, the EHR technology available to them does not support the level of data segmentation necessary to adhere to accepted best practices for patient confidentiality. If the Privacy Exception and the Preventing Harm Exception can be reasonably applied to some portions of the EHI, it may be appropriate to claim the Infeasibility Exception if the data segmentation functionality is not present.
      Finally, AAP published clinical use cases that assume that the request for EHI is coming from a patient or parent/guardian to a clinician, practice, or health system and which include guiding principles for adolescent clinical data [
      American Academy of Pediatrics
      Pediatric information blocking use cases.
      ]:
      • Adolescent patients should have access to their clinical data independent and separate from their parents/guardians.
      • Full release of all EHI to adolescents is not necessarily a solution. In some states (e.g., California), adolescents cannot have access to nonconfidential health information without parental consent.
      • There have been documented instances of guardians using an adolescent's portal login to access their child's health information. It is reasonable to establish security protocols to verify the identity of a requestor.
      • Laws vary by state/jurisdiction. The need for confidentiality between adolescent patients and their clinicians goes beyond what is allowable under most existing federal and state laws. Clinicians should be granted discretion in determining which EHI to withhold, under what circumstances, to best support the health and well-being of their adolescent patients.
      • All patients have the right to share their clinical data as they see fit.
      AAP also provided examples for the use of Cures Act Information Blocking Exceptions (e.g., preventing harm, privacy, and infeasibility) linked to specific clinical scenarios [
      American Academy of Pediatrics
      Pediatric information blocking use cases.
      ].
      In summary, current EHR and EHI sharing systems are not capturing opportunities to improve adolescent health care and health outcomes. Systems should support parent-teen communication regarding routine health care in a way that facilitates adolescents learning to manage their own health and health care as they approach adulthood, while simultaneously supporting adolescents' access to information about confidential health care when needed. New systems creatively designed to place EHI sharing within a developmental context are needed. EHRs must be developed to allow more fine-tuning of information release to patients and their families. These systems should be designed to serve the needs of adult patients who may request EHI sharing of routine health information with family members, but do not want to also disclose sensitive information regarding sexual health, mental health, and substance use [
      • Caine K.
      • Hanania R.
      Patients want granular privacy control over health information in electronic medical records.
      ]. These systems should also be designed to serve the needs of parents who disclose their own sensitive health information when pertinent to the child's health (e.g., maternal clinical histories, extensive genetic family histories, mental health and substance abuse histories), which is then incorporated into pediatric health records and may be disclosed to others, including to their own children at 18 years of age (or earlier) [
      American Academy of Pediatrics
      Pediatric information blocking use cases.
      ]. We support pragmatic creative solutions to address identified challenges, which will require collaboration among key stakeholders and EHR vendors. Ongoing research and evaluation to document potential benefits and risks of EHI sharing among adolescent patients and their parents that considers developmental context and timing is warranted [
      • Xie J.
      • McPherson T.
      • Powell A.
      • et al.
      Ensuring adolescent patient portal confidentiality in the age of the cures act final rule.
      ,
      • Parsons C.R.
      • Hron J.D.
      • Bourgeois F.C.
      Preserving privacy for pediatric patients and families: Use of confidential note types in pediatric ambulatory care.
      ]. Ongoing advocacy by national health-care organizations will be needed to ensure lifespan developmental context is considered while implementing the 21st Century Cures Act Final Rule, and that this implementation leads to improved health care and health of populations.

      Acknowledgments

      This information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by, HRSA, HHS, or the U.S. Government. The authors acknowledge with appreciation Megan C. Fisher Thiel MPH who provided technical support.

      Funding Sources

      This project was supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant numbers T71MC30798 , T71MC00009 , T71MC00006 , T71MC00003 , T71MC30799 and T71MC242101000 Leadership Education in Adolescent Health (LEAH).

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