An Entrustable Professional Activity (EPA)-Based Framework to Prepare Fourth-Year Medical Students for Internal Medicine Careers.

The purpose of the fourth year of medical school remains controversial. Competing demands during this transitional phase cause confusion for students and educators. In 2014, the Association of American Medical Colleges (AAMC) released 13 Core Entrustable Professional Activities for Entering Residency (CEPAERs). A committee comprising members of the Clerkship Directors in Internal Medicine and the Association of Program Directors in Internal Medicine applied these principles to preparing students for internal medicine residencies. The authors propose a curricular framework based on five CEPAERs that were felt to be most relevant to residency preparation, informed by prior stakeholder surveys. The critical areas outlined include entering orders, forming and answering clinical questions, conducting patient care handovers, collaborating interprofessionally, and recognizing patients requiring urgent care and initiating that care. For each CEPAER, the authors offer suggestions about instruction and assessment of competency. The fourth year of medical school can be rewarding for students, while adequately preparing them to begin residency, by addressing important elements defined in the core entrustable activities. Thus prepared, new residents can function safely and competently in supervised postgraduate settings.

How we developed and piloted an electronic key features examination for the internal medicine clerkship based on a US national curriculum.

BACKGROUND: Key features examinations (KFEs) have been used to assess clinical decision making in medical education, yet there are no reports of an online KFE-based on a national curriculum for the internal medicine clerkship. What we did: The authors developed and pilot tested an electronic KFE based on the US Clerkship Directors in Internal Medicine core curriculum. Teams, with expert oversight and peer review, developed key features (KFs) and cases. EVALUATION: The exam was pilot tested at eight medical schools with 162 third and fourth year medical students, of whom 96 (59.3%) responded to a survey. While most students reported that the exam was more difficult than a multiple choice question exam, 61 (83.3%) students agreed that it reflected problems seen in clinical practice and 51 (69.9%) students reported that it more accurately assessed the ability to make clinical decisions. CONCLUSIONS: The development of an electronic KFs exam is a time-intensive process. A team approach offers built-in peer review and accountability. Students, although not familiar with this format in the US, recognized it as authentically assessing clinical decision-making for problems commonly seen in the clerkship.

Content and timing of feedback and reflection: a multi-center qualitative study of experienced bedside teachers.

BACKGROUND: Competency-based medical education increasingly recognizes the importance of observation, feedback, and reflection for trainee development. Although bedside rounds provide opportunities for authentic workplace-based implementation of feedback and team-based reflection strategies, this relationship has not been well described. The authors sought to understand the content and timing of feedback and team-based reflection provided by bedside teachers in the context of patient-centered bedside rounds. METHODS: The authors conducted a thematic analysis qualitative study using transcripts from audio-recorded, semi-structured telephone interviews with internal medicine attending physicians (n= 34) identified as respected bedside teachers from 10 academic US institutions (2010-2011). RESULTS: Half of the respondents (50%) were associate/full professors, with an average of 14 years of academic experience. In the context of bedside encounters, bedside teachers reported providing feedback on history-taking, physical-examination, and case-presentation skills, patient-centered communication, clinical decision-making, leadership, teaching skills, and professionalism. Positive feedback about physical-exam skills or clinical decision-making occurred during encounters, positive or constructive team-based feedback occurred immediately following encounters, and individualized constructive feedback occurred in one-on-one settings following rounding sessions. Compared to less frequent, emotionally-charged events, bedside teachers initiated team-based reflection on commonplace "teachable moments" related to patient characteristics or emotions, trainee actions and emotions, and attending physician role modeling. CONCLUSIONS: Bedside teachers use bedside rounds as a workplace-based method to provide assessment, feedback, and reflection, which are aligned with the goals of competency-based medical education. Embedded in patient-centered activities, clinical teachers should be encouraged to incorporate these content- and timing-related feedback and reflection strategies into their bedside teaching.

The art of bedside rounds: a multi-center qualitative study of strategies used by experienced bedside teachers.

BACKGROUND: Medical educators believe bedside rounds are effective for the delivery of patient-centered care, and are necessary in helping trainees acquire competence in clinical care. Although recommendations for bedside rounds have been reported, a recent, systematic assessment of strategies used by current-day bedside teachers was needed to advance knowledge of this teaching method. OBJECTIVE: To identify and understand bedside teachers' 1) preparatory steps, 2) patient selection, and 3) role allocation during the process of bedside rounds. DESIGN: A qualitative inductive thematic analysis using transcripts from audio-recorded, semi-structured telephone interviews. PARTICIPANTS: Internal medicine physicians (n = 34) who perform bedside rounds from ten academic US institutions (2010-2011). APPROACH: A purposive sampling strategy was utilized to identify physicians who were active inpatient attending physicians and met specific inclusion criteria for "bedside rounds." A total of 34 interviews were completed, and each was recorded and transcribed verbatim. A thematic analysis extracted key themes pertaining to the three objectives. KEY RESULTS: Most respondents (51 %) were associate or full professors, with an average of 14 years of academic experience. Attending physicians prepared using trainee-specific, patient-specific and disease-specific information, while also mentally preparing for bedside rounds. They sought trainee buy-in and learning objectives, reviewed expectations and methods to ensure patient comfort, and provided early guidance with bedside encounters. Patients were selected if they required immediate care, were new to the service, or had a high educational value, while patients were deferred if unavailable, unwilling, or unable to communicate. The team members' roles during bedside rounds varied, with trainees being given graduated autonomy with increased experience. CONCLUSIONS: Bedside teachers' methods for preparation, patient selection, and role allocation during bedside rounds enhance trainees' education within the workplace. Strategies used by experienced bedside teachers can be used for faculty development efforts aimed at promoting this activity.

The value of bedside rounds: a multicenter qualitative study.

BACKGROUND: Bedside rounds have decreased on teaching services, raising concern about trainees' clinical skills and patient-physician relationships. PURPOSE: We sought to identify recognized bedside teachers' perceived value of bedside rounds to assist in the promotion of bedside rounds on teaching services. METHODS: Authors used a grounded theory, qualitative study design of telephone semistructured interviews with bedside teachers (n = 34) from 10 U.S. institutions (2010-2011). Main outcomes were characteristics of participants, themes pertaining to the perceived value of bedside rounds, and quotations highlighting each respective theme. RESULTS: The mean years in academic medicine was 13.7, and 51% were associate or full professors. Six main themes emerged: (a) skill development for learners (e.g., physical examination, communication, and clinical decision-making skills); (b) observation and feedback; (c) role-modeling; (d) team building among trainees, attending, and patient; (e) improved patient care delivery through combined clinical decision-making and team consensus; and (f) the culture of medicine as patient-centered care, which was embodied in all themes. CONCLUSIONS: Bedside teachers identify potential benefits of bedside rounds, many of which align with national calls to change our approach to medical education. The practice of bedside rounds enables activities essential to high-quality patient care and education.

Postinterview communication between military residency applicants and training programs.

PURPOSE: Each year military medical students participate in a separate, military match culminating with the Joint Services Graduate Medical Education Selection Board (JSGMESB). Prior studies have explored postinterview communication that occurs during the National Resident Matching Program (NRMP), but not during the JSGMESB. We examined the frequency and nature of communication during the JSGMESB and compared it with the NRMP. METHODS: Cross-sectional survey study of senior students conducted at Uniformed Services University of the Health Sciences (USU) and seven civilian U.S. medical schools during March to May 2010. Respondents answered questions regarding communication with residency programs during the match. RESULTS: Significantly fewer USU respondents communicated with programs compared with the civilian cohort (54.1% vs. 86.4%, p < 0.01). Specific inquiries regarding rank order were more commonly experienced by USU respondents compared with civilians (17.5% vs. 4.8%, p = 0.02). USU respondents found postinterview communication both helpful (41.3%) and stressful (41.3%). 11.1% of USU respondents indicated that they moved a program higher on their final rank lists because of further communication with these programs. CONCLUSIONS: Postinterview communication during the JSGMESB process is less common and less stressful than that reported in the NRMP. USU respondents are more likely to be asked directly about their rank list and occasionally do change their lists. Uniform guidance mirroring the NRMP's dealing with direct inquiries about rank lists could potentially improve the process.

Physical Examination in the Evaluation of Dementia.

Dementia is a common disease worldwide and is largely underdiagnosed. A timely diagnosis of dementia is beneficial for both the patient and family for many reasons, and exclusion and treatment of other mimics of dementia are crucial to avoid long-term consequences. Making a diagnosis of dementia requires attention to subtle cues from both patients and other informants, as often patients and family members will not notice early signs and symptoms. Although universal screening is not recommended by the USPSTF, screening in high-risk populations is recommended by many organizations. Screening with the Mini-Cog and AD8 combined is a highly sensitive way to identify patients with dementia, and confirmation testing can be performed with the MoCA or MMSE. Specific subtypes of dementia, including Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia, and others, sometimes can be differentiated by unique physical examination findings. Timely referral to dementia specialists is useful in the management of this group of diseases. However, as the aging population grows and access to specialists is often limited, it is important for all physicians to understand how to make a diagnosis of dementia.

Perception of Medical Student Mistreatment: Does Specialty Matter?

PURPOSE: Medical student mistreatment is pervasive, yet whether all physicians have a shared understanding of the problem is unclear. The authors presented professionally designed trigger videos to physicians from 6 different specialties to determine if they perceive mistreatment and its severity similarly. METHOD: From October 2016 to August 2018, resident and attending physicians from 10 U.S. medical schools viewed 5 trigger videos showing behaviors that could be perceived as mistreatment. They completed a survey exploring their perceptions. The authors compared perceptions of mistreatment across specialties and, for each scenario, evaluated the relationship between specialty and perception of mistreatment. RESULTS: Six-hundred fifty resident and attending physicians participated. There were statistically significant differences in perception of mistreatment across specialties for 3 of the 5 scenarios: aggressive questioning (range, 74.1%-91.2%), negative feedback (range, 25.4%-63.7%), and assignment of inappropriate tasks (range, 5.5%-25.5%) (P ≤ .001, for all). After adjusting for gender, race, professional role, and prior mistreatment, physicians in surgery viewed 3 scenarios (aggressive questioning, negative feedback, and inappropriate tasks) as less likely to represent mistreatment compared with internal medicine physicians. Physicians from obstetrics-gynecology and "other" specialties perceived less mistreatment in 2 scenarios (aggressive questioning and negative feedback), while family physicians perceived more mistreatment in 1 scenario (negative feedback) compared with internal medicine physicians. The mean severity of perceived mistreatment on a 1 to 7 scale (7 most serious) also varied statistically significantly across the specialties for 3 scenarios: aggressive questioning (range, 4.4-5.4; P < .001), ethnic insensitivity (range, 5.1-6.1; P = .001), and sexual harassment (range, 5.5-6.3; P = .004). CONCLUSIONS: Specialty was associated with differences in the perception of mistreatment and rating of its severity. Further investigation is needed to understand why these perceptions of mistreatment vary among specialties and how to address these differences.

Impact of Match Violations on Applicants' Perceptions and Rankings of Residency Programs.

Introduction The National Resident Matching Program (NRMP) requires all Match participants to adhere to a strict code of conduct known as the Match Participation Agreement, yet Match violations continue to occur. We sought to determine how interview experiences, including Match violations, impact applicants' perceptions and rankings of residency programs. Methods An electronic survey was sent to all accredited medical school Deans of Student Affairs and Association of American Medical Colleges Student Representatives for distribution to fourth-year medical students. Questions assessed pressures that residency programs placed on applicants during interview season and their impact on applicants. Both quantitative and qualitative data were collected. Results Of the 433 included respondents, 31.2% (n = 135) reported breaches of the NRMP Match Participation Agreement. Of those, 63% (n = 85) had a negative perception of the violating programs, and 37.8% (n = 51) were less likely to rank those programs highly. Violations included asking applicants about the locations of their other interviews (60.3%, n = 261), pressuring applicants to reveal their ranking (24.0%, n = 104), explicitly requesting applicants to reveal their ranking (6.5%, n = 28), asking applicants to provide a commitment before Match day (3.9%, n = 17), and other behavior that was felt to ignore the spirit of the Match (16.4%, n = 71). Implying that applicants would match into a program if they ranked it highly (37.2%, n = 161) was received positively by 65.2% (n = 105) of applicants experiencing this breach, with 42.2% (n = 68) ranking the program more highly. Three major themes impacting applicants' impressions of residency programs emerged from the qualitative data: interview experience, professionalism, and post-interview communication (PIC). Respondents overwhelmingly agreed that PIC should either be eliminated or that programs should set clear expectations for PIC. Conclusions Match violations continue to occur, despite the NRMP Match Participation Agreement. With the notable exception of communication implying that applicants would match into a program, applicants overwhelmingly view programs that commit these violations negatively and often rank these programs lower as a result.

Validity Evidence for a Brief Online Key Features Examination in the Internal Medicine Clerkship.

PURPOSE: Medical educators use key features examinations (KFEs) to assess clinical decision making in many countries, but not in U.S. medical schools. The authors developed an online KFE to assess third-year medical students' decision-making abilities during internal medicine (IM) clerkships in the United States. They used Messick's unified validity framework to gather validity evidence regarding response process, internal structure, and relationship to other variables. METHOD: From February 2012 through January 2013, 759 students (at eight U.S. medical schools) had 75 minutes to complete one of four KFE forms during their IM clerkship. They also completed a survey regarding their experiences. The authors performed item analyses and generalizability studies, comparing KFE scores with prior clinical experience and National Board of Medical Examiners Subject Examination (NBME-SE) scores. RESULTS: Five hundred fifteen (67.9%) students consented to participate. Across KFE forms, mean scores ranged from 54.6% to 60.3% (standard deviation 8.4-9.6%), and Phi-coefficients ranged from 0.36 to 0.52. Adding five cases to the most reliable form would increase the Phi-coefficient to 0.59. Removing the least discriminating case from the two most reliable forms would increase the alpha coefficient to, respectively, 0.58 and 0.57. The main source of variance came from the interaction of students (nested in schools) and cases. Correlation between KFE and NBME-SE scores ranged from 0.24 to 0.47 (P < .01). CONCLUSIONS: These results provide strong evidence for response-process and relationship-to-other-variables validity and moderate internal structure validity for using a KFE to complement other assessments in U.S. IM clerkships.

Between two worlds: a multi-institutional qualitative analysis of students' reflections on joining the medical profession.

BACKGROUND: Recent changes in healthcare system and training mandates have altered the clinical learning environment. We incorporated reflective writing into Internal Medicine clerkships (IMcs) in multiple institutions so students could consider the impact of clerkship experiences on their personal and professional development. We analyzed student reflections to inform curricula and support learning. METHODS: We qualitatively analyzed the reflections of students at 3 US medical schools during IMcs (N = 292) to identify themes, tone, and reflective quality using an iterative approach. Chi-square tests assessed differences between these factors and across institutions. FINDINGS: Students openly described powerful experiences. Major themes focused on 4 categories: personal issues (PI), professional development (PD), relational issues (RI), and medical care (MC). Each major theme was represented at each institution, although with significant variability between institutions in many of the subcategories including student role (PI), development-as-a-physician (PD), professionalism (PD) (p < 0.001). Students used positive tones to describe student role, development-as-a-physician and physician-patient relationship (PD) (p < 0.01-0.001), and negative tones for quality and safety (MC) (p < 0.05). Only 4% of writings coded as professionalism had a positive tone. Students employed a "reporting" voice in writing about clinical problem-solving, healthcare systems, and quality/safety (MC). DISCUSSION: Reflection is considered important to professional development. Our analysis suggests that students at 3 institutions reflect on similar experiences. Theme variability across institutions implies curricula should be tailored to local culture. Reflective quality analysis suggests students are better equipped to reflect on certain experiences over others, which may impact learning. Student reflections can function as a mirror for our organizations, offer institutional feedback for support and improvement, and inform curricula for learners and faculty.

Factors associated with medical students' career choices regarding internal medicine.

CONTEXT: Shortfalls in the US physician workforce are anticipated as the population ages and medical students' interest in careers in internal medicine (IM) has declined (particularly general IM, the primary specialty serving older adults). The factors influencing current students' career choices regarding IM are unclear. OBJECTIVES: To describe medical students' career decision making regarding IM and to identify modifiable factors related to this decision making. DESIGN, SETTING, AND PARTICIPANTS: Web-based cross-sectional survey of 1177 fourth-year medical students (82% response rate) at 11 US medical schools in spring 2007. MAIN OUTCOME MEASURES: Demographics, debt, educational experiences, and number who chose or considered IM careers were measured. Factor analysis was performed to assess influences on career chosen. Logistic regression analysis was conducted to assess independent association of variables with IM career choice. RESULTS: Of 1177 respondents, 274 (23.2%) planned careers in IM, including 24 (2.0%) in general IM. Only 228 (19.4%) responded that their core IM clerkship made a career in general IM seem more attractive, whereas 574 (48.8%) responded that it made a career in subspecialty IM more attractive. Three factors influenced career choice regarding IM: educational experiences in IM, the nature of patient care in IM, and lifestyle. Students were more likely to pursue careers in IM if they were male (odds ratio [OR] 1.75; 95% confidence interval [CI], 1.20-2.56), were attending a private school (OR, 1.88; 95% CI, 1.26-2.83), were favorably impressed with their educational experience in IM (OR, 4.57; 95% CI, 3.01-6.93), reported favorable feelings about caring for IM patients (OR, 8.72; 95% CI, 6.03-12.62), or reported a favorable impression of internists' lifestyle (OR, 2.00; 95% CI, 1.39-2.87). CONCLUSIONS: Medical students valued the teaching during IM clerkships but expressed serious reservations about IM as a career. Students who reported more favorable impressions of the patients cared for by internists, the IM practice environment, and internists' lifestyle were more likely to pursue a career in IM.

Current and Optimal Training in High-Value Care in the Internal Medicine Clerkship: A National Curricular Needs Assessment.

PURPOSE: The clinical skills needed to practice high-value care (HVC) are core to all medical disciplines. Medical students form practice habits early, and HVC instruction is essential to this formation. The purpose of this study was to describe the state of HVC instruction and assessment in internal medicine clerkships and identify needs for additional curricula. METHOD: In 2014, the Clerkship Directors in Internal Medicine conducted its annual survey of 121 U.S. and Canadian medical schools. The authors evaluated a subset of questions from that survey asking clerkship directors about the perceived importance of HVC instruction, type and amount of formal instruction and assessment, achievement of student competence, prioritization of topics, and barriers to curriculum implementation. Descriptive statistics were used to summarize responses, and chi-square tests were used to examine associations between response categories. RESULTS: The overall response rate was 77.7% (94/121). The majority (85; 91.4%) agreed that medical schools have a responsibility to teach about HVC across all phases of the curriculum. Of respondents, 31 (32.9%) reported their curricula as having some formal instruction on HVC, and 66 (70.2%) felt the amount was inadequate. Highest-priority topics for inclusion included overuse of diagnostic tests and treatments, defining value and its application to clinical reasoning, and balancing benefit and harm. Only 11 (17.8%) assessed students' competence in HVC. CONCLUSIONS: Internal medicine clerkship directors reported that HVC is insufficiently taught and assessed in medical school, despite relevance to practice. Developing generalizable curricular materials, faculty development, and dedicated curricular time may enhance HVC education.

Bioreactor production of recombinant herpes simplex virus vectors.

Serotypical application of herpes simplex virus (HSV) vectors to gene therapy (type 1) and prophylactic vaccines (types 1 and 2) has garnered substantial clinical interest recently. HSV vectors and amplicons have also been employed as helper virus constructs for manufacture of the dependovirus adeno-associated virus (AAV). Large quantities of infectious HSV stocks are requisite for these therapeutic applications, requiring a scalable vector manufacturing and processing platform comprised of unit operations which accommodate the fragility of HSV. In this study, production of a replication deficient rHSV-1 vector bearing the rep and cap genes of AAV-2 (denoted rHSV-rep2/cap2) was investigated. Adaptation of rHSV production from T225 flasks to a packed bed, fed-batch bioreactor permitted an 1100-fold increment in total vector production without a decrease in specific vector yield (pfu/cell). The fed-batch bioreactor system afforded a rHSV-rep2/cap2 vector recovery of 2.8 x 10(12) pfu. The recovered vector was concentrated by tangential flow filtration (TFF), permitting vector stocks to be formulated at greater than 1.5 x 10(9) pfu/mL.

Transgenerational epigenetics and environmental justice.

Human transmission to offspring and future generations of acquired epigenetic modifications has not been definitively established, although there are several environmental exposures with suggestive evidence. This article uses three examples of hazardous substances with greater exposures in vulnerable populations: pesticides, lead, and diesel exhaust. It then considers whether, if there were scientific evidence of transgenerational epigenetic inheritance, there would be greater attention given to concerns about environmental justice in environmental laws, regulations, and policies at all levels of government. To provide a broader perspective on environmental justice the article discusses two of the most commonly cited approaches to environmental justice. John Rawls's theory of justice as fairness, a form of egalitarianism, is frequently invoked for the principle that differential treatment of individuals is justified only if actions are designed to benefit those with the greatest need. Another theory, the capabilities approach of Amartya Sen and Martha Nussbaum, focuses on whether essential capabilities of society, such as life and health, are made available to all individuals. In applying principles of environmental justice the article considers whether there is a heightened societal obligation to protect the most vulnerable individuals from hazardous exposures that could adversely affect their offspring through epigenetic mechanisms. It concludes that unless there were compelling evidence of transgenerational epigenetic harms, it is unlikely that there would be a significant impetus to adopt new policies to prevent epigenetic harms by invoking principles of environmental justice.

Not the same everywhere. Patient-centered learning environments at nine medical schools.

BACKGROUND: Learning environments overtly or implicitly address patient-centered values and have been the focus of research for more than 40 years, often in studies about the "hidden curriculum." However, many of these studies occurred at single medical schools and used time-intensive ethnographic methods. This field of inquiry lacks survey methods and information about how learning environments differ across medical schools. OBJECTIVE: To examine patient-centered characteristics of learning environments at 9 U.S. medical schools. DESIGN: Cross-sectional internet-based survey. PARTICIPANTS: Eight-hundred and twenty-three third- and fourth-year medical students in the classes of 2002 and 2003. MEASUREMENTS: We measured the patient-centeredness of learning environments with the Communication, Curriculum, and Culture (C3) Instrument, a 29-item validated measure that characterizes the degree to which a medical school's environment fosters patient-centered care. The C3 Instrument contains 3 content areas (role modeling, students' experiences, and support for students' patient-centered behaviors), and is designed to measure these areas independent of respondents' attitudes about patient-centered care. We also collected demographic and attitudinal information from respondents. RESULTS: The variability of C3 scores across schools in each of the 3 content areas of the instrument was striking and statistically significant (P values ranged from .001 to .004). In addition, the patterns of scores on the 3 content areas differed from school to school. CONCLUSIONS: The 9 schools demonstrated unique and different learning environments both in terms of magnitude and patterns of characteristics. Further multiinstitutional study of hidden curricula is needed to further establish the degree of variability that exists, and to assist educators in making informed choices about how to intervene at their own schools.

Biobanking Research and Privacy Laws in the United States.

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU-US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Comparative Approaches to Biobanks and Privacy.

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.