Health Insurance Portability And Accountability Research Articles

Enhancing Healthcare Data Security Using Quantum Cryptography for Efficient and Robust Encryption

Healthcare requires data encryption to safeguard sensitive patient information from unauthorized access or breaches. Encryption ensures that data is encoded into a secure format, making it unreadable to anyone without the decryption key. This helps maintain patient privacy, protects against identity theft, and ensures compliance with data protection regulations like HIPAA (Health Insurance Portability and Accountability Act.). With encryption, healthcare organizations can mitigate the risk of data breaches and uphold trust with patients by ensuring the confidentiality and integrity of their medical records and personal information. Quantum cryptography emerges as a revolutionary solution, offering unparalleled encryption for healthcare data. This process initiates with the meticulous crafting of quantum states to encapsulate healthcare data securely, ensuring precise encoding. Subsequently, quantum entanglement is established between sender and receiver, creating a secure communication channel resistant to interception attempts. Quantum key distribution then generates a secure key leveraging entangled quantum states, becoming the cornerstone of encryption. Quantum encryption shields healthcare data in an impenetrable veil of secrecy, leveraging the complexities of quantum mechanics to thwart unauthorized decryption attempts. The decryption process, facilitated by the shared secure key, unveils the encrypted healthcare data exclusively to authorized parties, preserving confidentiality with unparalleled precision. The result reveals quantum cryptography's superiority in healthcare data encryption. At 150-bit key length, quantum cryptography takes 352,237 milliseconds vs. AES's 310,285 milliseconds. For a 14 KB input, quantum cryptography requires 7 milliseconds compared to AES's 12 milliseconds. These metrics highlight quantum cryptography's efficiency gains and transformative potential in healthcare data security, promising both enhanced security and efficiency benefits.

Enhancing Healthcare Data Security Using Quantum Cryptography for Efficient and Robust Encryption

Healthcare requires data encryption to safeguard sensitive patient information from unauthorized access or breaches. Encryption ensures that data is encoded into a secure format, making it unreadable to anyone without the decryption key. This helps maintain patient privacy, protects against identity theft, and ensures compliance with data protection regulations like HIPAA (Health Insurance Portability and Accountability Act.). With encryption, healthcare organizations can mitigate the risk of data breaches and uphold trust with patients by ensuring the confidentiality and integrity of their medical records and personal information. Quantum cryptography emerges as a revolutionary solution, offering unparalleled encryption for healthcare data. This process initiates with the meticulous crafting of quantum states to encapsulate healthcare data securely, ensuring precise encoding. Subsequently, quantum entanglement is established between sender and receiver, creating a secure communication channel resistant to interception attempts. Quantum key distribution then generates a secure key leveraging entangled quantum states, becoming the cornerstone of encryption. Quantum encryption shields healthcare data in an impenetrable veil of secrecy, leveraging the complexities of quantum mechanics to thwart unauthorized decryption attempts. The decryption process, facilitated by the shared secure key, unveils the encrypted healthcare data exclusively to authorized parties, preserving confidentiality with unparalleled precision. The result reveals quantum cryptography's superiority in healthcare data encryption. At 150-bit key length, quantum cryptography takes 352,237 milliseconds vs. AES's 310,285 milliseconds. For a 14 KB input, quantum cryptography requires 7 milliseconds compared to AES's 12 milliseconds. These metrics highlight quantum cryptography's efficiency gains and transformative potential in healthcare data security, promising both enhanced security and efficiency benefits.

How Sharp Objects Injuries Impact our Healthcare Workers: Unveiling Perspective and Preventive Imperatives.

Introduction Sharp object injuries in the medical field present a considerable occupational hazard for healthcare workers (HCWs), encompassing a spectrum of consequences from immediate discomfort to enduring health consequences. These injuries may expose HCWs to potential infections. Despite efforts to control sharp object injuries in healthcare environments, they are present at every stage involving using or disposing of medical sharp instruments. In Jordan, limited research has focused on sharp object injuries, with most data included from studies concentrating on practicing nurses or nursing students. Consequently, further research is necessary to comprehend the causes behind the high sharp object injury rate and the insufficient knowledge of safety practices and preventive guidelines. Objectives This study was conducted to investigate the impact of sharp object injuries on HCWs, underlying causes,and potential consequences causes of needlestick injuries. To highlight perspective and preventive imperatives. Methods and patients This retrospective institutional-based cross-sectional chart analysis was conducted by reviewing all sharp object injuries report sheets and extracting data directly from these reports for analysis. The study encompassed all reported cases occurring between 2018 and 2023. All the participants' data handling was accomplished according to the Declaration of Helsinki (2013) and the Health Insurance Portability and Accountability (HIPAA) Acts. Results A total of 146 self-reported hospital workers were included in the study. Within the final cohort, 52.73% of the participants were male (77/146), with an average age at diagnosis of 38.6±7.87 years (ranging from 20 to 52 years). Conversely, females comprised 47.27% of the cohort population (69/146) and had an average age at diagnosis of 34.73±6.73 years (ranging from 19 to 47 years). The age group 20-29 years was the most prominent age group, statistical analysis of age and gender data revealed significant differences. The overall prevalence of sharp object injuries was 11.83%, indicating that a sizable portion of HCWs is at risk of exposure to bloodborne pathogens. Among the different professional categories, Physicians constituted the majority of sharp object injuries reported victims in 41 cases (28.08%), followed by nurses in 38 cases (26.02%).Statistical analysis of the profession's data revealed significant differences (P<0.001). Notably, sharp object injuries were most reported in wards. The leading procedures that caused sharp object injuries were identified as during needle recapping in 53 instances (36.30%), then followed by medical waste treatment in 32 cases (21.92%). The left hand was the most affected body part, reported in 83 cases (56.84%).All injured individuals reported the incident promptly. No seroconversions were documented within the reviewed cases during the study period. Conclusion Injuries caused by sharp objects persist as a significant danger for hospital employees, posing immediate harm and long-term health risks linked to bloodborne pathogens. The findings stress the continuous responsibility of healthcare institutions to prioritize staff safety by addressing the root causes of sharp object injuries and fostering reporting and prevention cultures. Underreporting reasons are diverse, encompassing factors like time constraints, fear of consequences, and the misconception of injury insignificance.

DEONTOLOGICAL ASPECTS IN THE IMPLEMENTATION OF P-Care AT THE FIRST LEVEL OF HEALTH FACILITIES IN YOGYAKARTA CITY

Abstract: Deontological Aspects in The Implementation of P-Care at TheFirst Level of Health Facilities in Yogyakarta City. The 2015 SustainableDevelopment Goals (SDGs) opened a new focus on Universal Health Coverage (UHC).In Indonesia, the UHC concept has been proclaimed since 2000 which is thenorganized by Badan Penyelenggara Jaminan Sosial (BPJS) following the Law of theRepublic of Indonesia number 24 of 2011 Article 9 concerning the National SecurityAdministering Body. In implementing Indonesia’s national health insurance (JKN),BPJS kesehatan uses a cloud-based information system for Fasilitas KesehatanTingkat Pertama (FKTP) / The first level health facility, namely Primary Care (P-Care)which contains medical information for more than 222 million people. According tothe Health Insurance Portability and Accountability (HIPAA), data in P-Care includesProtected Health Information (PHI) which can lead to potential ethical violations. Thisstudy aims to determine ethical issues from the Deontology aspect related to theapplication of P-Care in FKTPs in Yogyakarta City. The Method of research is thesequential exploratory mix method. The deontology point of view was chosen becausethe principle of Deontology, namely personal intrinsic value cannot be separated fromethical issues. The results showed that there are ethical issues in the application ofP-Care in FKTPs in Yogyakarta City, namely privacy and confidentiality, security, andinformed consent with the important issue being the involvement of third parties inP-Care data input, P-Care which can be accessed anywhere, lack of personalvalidation, as well as a printed diagnosis that anyone can read. The most powerfulinfluencing factor is the intrinsic value of each agent in understanding these ethicalissues.

Evolving teledermatology policy and reimbursement landscape in the United States

Policymakers and payers are reevaluating the temporary telehealth flexibilities granted during the COVID-19 public health emergency, which will shape future teledermatology utilization. To summarize the recently expanded telehealth flexibilities in the United States, projected changes, and corresponding implications for dermatologists. Narrative review of the literature, United States policies and regulations, and white paper reports. Key telehealth flexibilities included expansion of payment parity, relaxation of originating site requirements, loosening of state licensure requirements, and HIPAA (Health Insurance Portability and Accountability Act of 1996) enforcement discretion. These changes enabled widespread accessibility and adoption of teledermatology, which enhanced high-quality and cost-effective dermatologic care. Most waivers will end 151days following the end of the public health emergency declaration. Notably, asynchronous telehealth was not included in the reimbursement expansion. Only policies and regulations through December 2022 are included. It will be important for the field of dermatology to stay abreast of the upcoming changes in telemedicine policies and reimbursement, to demonstrate teledermatology's value through evidence-based studies and to advocate for enduring policies that will promote the accessibility of teledermatology for patients.

The correlation of fractional anisotropy parameters with Ki-67 index, and the clinical implication in grading of non-enhancing gliomas and neuronal-glial tumors

PurposeTo investigate the correlation between the FA parameters and Ki-67 labeling index, and their diagnostic performance in grading supratentorial non-enhancing gliomas and neuronal-glial tumors (GNGT). MethodsThis institutional review board-approved, Health Insurance Portability and Accountability (HIPAA) compliant retrospective study enrolled 35 patients, including 19 with low grade GNGT and 16 with high grade GNGT. The mean FA, maximal FA and mean maximal FA values derived from diffusion tensor imaging were measured. The correlation between the FA parameters and the Ki-67 labeling index was assessed by Spearman rank test. The receiver operating characteristic curve analysis and multivariate logistic regression analysis were performed to detect the optimal imaging parameters in grading GNGT. ResultsThe three FA parameters of low grade GNGT were significantly lower than the high grade GNGT (p < 0.001). The mean FA, maximal FA and mean maximal FA had significant positive correlation with Ki-67 labeling index (p = 0.001, p < 0.001, p < 0.001 respectively). The maximal FA showed a higher sensitivity and specificity in grading of non-enhancing GNGT with specificity of 78.9%, sensitivity of 100.0%, respectively. ConclusionsThe FA parameters correlated with Ki-67 labeling index, and were useful surrogates in preoperative grading supratentorial non-enhancing GNGT.

Accurate estimation of diffusion kurtosis (DK) imaging parameters of the prostate

Purpose: To evaluate the performance of maximum likelihood (ML) estimation of diffusion kurtosis (DK) imaging parameters in the prostate and compare the estimated parameters to those measured using least squares (LS) estimation. Materials and methods: The institutional review board issued a waiver of informed consent for this Health Insurance Portability and Accountability Act (HIPAA)-compliant, retrospective study of forty-two patients (median [Md] age=61 years; range: 43-74 years) who underwent magnetic resonance imaging (MRI) between September and October 2016. Diffusion-weighted MRI (DW-MRI) at nine b-values (0-2000 s/mm2 ) were acquired using a 3-T whole-body MRI unit (Discovery MR750; GE Medical Systems, Waukesha, WI) equipped with an eight-channel phased array coil for signal reception. Diffusion coefficient (D) and kurtosis (K) were estimated from the normal appearing prostate peripheral zone and prostate cancer regions of interest (ROIs). The parameters were estimated by fitting the measured MR signal intensities as a function of b-value, using LS and ML algorithms. An estimate of the noise was obtained on the b=0 images in an artifact-free ROI in the rectum. Simulations were also carried out to assess the properties of the two estimators in a range of signal-to-noise ratios. Results: For benign ROIs, the mean D ± standard deviation, (1.88±0.52)×10-3 mm2 /sec, and mean K (0.79±0.20), measured using LS estimation, differed significantly from the mean D (1.96±0.48)×10-3 mm2 /sec and mean K (0.68±0.21), measured using ML estimation (P&lt;0.001 for both). For malignant ROIs, the mean D (1.48±0.38)×10-3 mm2 /sec and mean K (0.94±0.20), measured using LS estimation, differed significantly from the mean D (1.54±0.36)×10-3 mm2 /sec and mean K (0.81±0.19), measured using ML estimation (P&lt;0.001 for both). Simulations demonstrate that ML minimizes the bias estimate of DK parameters within the signal-to-noise ratio range of 5-15. Conclusion: By incorporating the noise level, the ML estimation increases the accuracy of DK parameter estimation. In vivo results with phased array coils showed significant differences in DK parameter estimates with ML as compared with the standard LS estimation.

MRI of suspected appendicitis during pregnancy: interradiologist agreement, indeterminate interpretation and the meaning of non-visualization of the appendix.

To determine the degree of interradiologist agreement between the MRI features of appendicitis during pregnancy, the outcomes associated with an indeterminate interpretation and the negative predictive value of non-visualization of the appendix. Our study was approved by the institutional review board at the Washington University in St. Louis, Missouri (WUStL) and was HIPAA (Health Insurance Portability and Accountability Act of 1996)-compliant. The informed consent requirement was waived. Cases of suspected appendicitis during pregnancy evaluated using MRI were retrospectively identified using search queries. Scans were re-reviewed by two radiologists (7 and 9 years experience, respectively) to evaluate the interradiologist agreement of different MRI features of appendicitis during pregnancy (visualization of the appendix, appendiceal diameter, appendiceal wall thickening, periappendiceal fat stranding, fluid-filled appendix and periappendiceal fluid). The radiologists were blinded to patient outcome, patient intervention, laboratory data, demographic data and the original MRI reports. Clinical outcomes were documented by surgical pathology or clinical observation. Interradiologist agreement was analysed using Cohen's κ, while patient demographic and clinical data was analysed using Student's t-testing. 233 females with suspected appendicitis during pregnancy were evaluated using MRI over a 13-year period (mean age, 28.4 years; range, 17-38 years). There were 14 (6%) positive examinations for appendicitis during pregnancy, including 1 patient whose MRI was interpreted as negative, proven by surgical pathology. The presence of periappendiceal soft-tissue stranding and the final overall impression had the most interradiologist agreement (к = 0.81-1). There were no pregnant patients found to have acute appendicitis who had an indeterminate MR interpretation or when the appendix could not be visualized. The final impression by the two retrospectively reviewing radiologists of MR examinations performed for suspected appendicitis during pregnancy had near-perfect agreement. In patients where the appendix could not be visualized or in patients that were interpreted as indeterminate, no patients had acute appendicitis. Advances in knowledge: MR impression for suspected appendicitis in the pregnant patient has high interradiologist agreement, and a non-visualized appendix or lack of inflammatory findings at the time of MR, reliably excludes surgical appendicitis.

Limbic pathway lesions in patients with multiple sclerosis

Multiple sclerosis (MS) is a well-known demyelinating disease to cause cognitive dysfunction. The limbic system, relevant to memory, can be easily overlooked in conventional magnetic resonance imaging (MRI). To investigate the distribution and frequency of demyelinating lesions affecting white matter connections of the limbic system based on localization with diffusion tensor imaging (DTI)-derived fractional anisotropy (FA) color maps compared to three-dimensional T2-weighted (T2W) and FLAIR volumes in MS patients. One hundred and fifty patients with a known diagnosis of MS were identified for this Health Insurance Portability and Accountability (HIPAA)-compliant retrospective cross-sectional study. DTI-derived FA color maps, co-registered to T2W and FLAIR images, were analyzed for lesions affecting the three white matter tracts of the limbic system including cingulum, fornix, and mammilothalamic tracts by two investigators. The approximate location of the lesions on FLAIR was always confirmed on the co-registered DTI-derived FA color maps. Of the 150 patients analyzed, 14.6% had cingulum lesions, 2.6% had fornix lesions, and 2.6% had mammilothalamic tract lesions; 21.3% of patients had at least one of the three tracts affected. A relatively high frequency of lesions involving the limbic tracts may explain memory deficits and emotional dysfunction commonly experienced by patients with MS. The combined information from T2W, FLAIR, and DTI-derived FA color map allowed for more accurate localization of lesions affecting the major white matter tracts of the limbic system.

Do characteristics of pulmonary nodules on computed tomography in children with known osteosarcoma help distinguish whether the nodules are malignant or benign?

PurposeTo determine if selected computed tomography (CT) characteristics of pulmonary nodules in pediatric patients with osteosarcoma can help distinguish the nodules as benign or malignant. MethodsThe institutional review board approved this HIPAA (Health Insurance Portability and Accountability Act-compliant, retrospective study of 30 pediatric osteosarcoma patients (median age 14 years, range 8-22) who underwent chest CT with resection of 117 pulmonary nodules from January 2001 to December 2006. Two pediatric radiologists and one chest radiologist independently and retrospectively reviewed the CT scans and classified nodules as benign, malignant, or indeterminate on the basis of nodule size, laterality, number, location, growth, density, margin appearance, and calcification. Generalized estimating equations were used to examine which characteristics were independent predictors of nodule malignancy. ResultsOf the 117 nodules, 80 (68%) were malignant and 37 (32%) were benign by pathologic review. The readers correctly classified 93% to 94% of the malignant nodules. For benign lesions, the results were not as accurate, with the readers correctly classifying only 11% to 30% of lesions. Most of the benign lesions were classified as indeterminate by the readers (54%-65%). Nodule size (≥5 mm) and the presence of calcifications were associated with an increased probability of malignancy (P < .05). ConclusionOn chest CT, nodule size 5 mm or greater and the presence of calcifications are associated with an increased probability of malignant nodule histology in pediatric patients with osteosarcoma. However, nodule characteristics, apart from size and calcification, at chest CT cannot reliably distinguish benign from malignant pulmonary nodules in these patients.

FAQs About HIPAA and HITECH: What Physicians Need to Know

Back to table of contents Previous article Next article Professional NewsFull AccessFAQs About HIPAA and HITECH: What Physicians Need to KnowDonna Vanderpool, M.B.A., J.D.Donna VanderpoolSearch for more papers by this author, M.B.A., J.D.Published Online:1 Jan 2010https://doi.org/10.1176/pn.45.1.psychnews_45_1_017AbstractThe HITECH (Health Information Technology for Economic and Clinical Health) Act is Title 13 of the American Recovery and Reinvestment Act of 2009 (ARRA). While the various subtitles of HITECH cover many topics relevant to physicians (for example, financial incentives for health information technology), this article will address only Subtitle D of HITECH amending the privacy and security rules under HIPAA (Health Insurance Portability and Accountability Act of 1996).HIPAA's privacy and security rules established floors of confidentiality and security protections for patients' demographic and health information in all forms—paper, oral, and electronic. The development of health information technology (for example, electronic health records, personal health records, health information exchanges) has resulted in additional risks; HITECH builds on the privacy and security rules to address these new risks.•. Who must comply with the HITECH amendments to HIPAA?Covered entities and business associates under HIPAA must comply with HIPAA, as amended by HITECH.•. Isn't every physician a covered entity under HIPAA?No. Only providers who electronically submit specific transactions electronically are covered by (required to comply with) HIPAA. The most common transaction that makes a provider covered is the electronic submission of claims to health plans. The Department of Health and Human Services (HHS) has useful resources to determine the applicability of the federal HIPAA regulations posted at <www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html>.•. What is a business associate?Under the privacy rule, a business associate is a person who provides a function on behalf of a covered entity (other than as part of the covered entity's workforce) that involves the use of protected health information (PHI). Examples of this type of business associate include billing services, transcription services, and answering services. A business associate is also a person who provides specified services involving the use of PHI to a covered entity. The specified services are legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, and financial services. The HHS Web site at <www.hhs.gov/ocr/privacy> has much more information on entities that are, and are not, business associates.Business associates may use and disclose PHI, but only in compliance with the business associate agreement evidencing the business associate's promise to maintain the confidentiality and security of PHI. Under existing law, business associates only have contractual liability with the covered entity via the business associate agreement. As of February 2010, business associates must comply with the security rule and will be subject to government enforcement.•. What does HITECH say about HIPAA?There are many changes to HIPAA under HITECH, but not all of the provisions have the same effective date. See Summary Timeline for HITECH Requirements for Providers Covered Under HIPAA for a summary timeline showing the implications of the major HITECH provisions on HIPAA-covered entities.The most significant provisions of HITECH include the following: •. Increasing enforcement of existing HIPAA regulations (privacy and security rules). •. Increasing penalties for violations of existing HIPAA regulations. •. Adding a new federal breach notification law. •. Subjecting business associates to government enforcement.Part 2 of this article will include FAQs on enforcement and compliance with HIPAA, as well as breach notification. Please note that nothing in this article should be construed as legal advice.Donna Vanderpool, M.B.A., J.D., is assistant vice president, risk management, at Professional Risk Management Services Inc. (PRMS Inc.). ISSUES NewArchived

Impact of the Privacy Rule on the Study of Out-of-Hospital Pediatric Cardiac Arrest

Introduction. The Privacy Rule, a follow-up to the Health Insurance Portability andAccountability Act, limits distribution of protected health information. Compliance with the Privacy Rule is particularly challenging for prehospital research, because investigators often seek data from multiple emergency medical services (EMS) andreceiving hospitals. Objective. To describe the impact of the Privacy Rule on prehospital research andto present strategies to optimize data collection in compliance with the Privacy Rule. Methods. The CanAm Pediatric Cardiopulmonary Arrest Study Group has previously conducted a multicentered observational study involving children with out-of-hospital cardiac arrest. In the current study, we used a survey to assess site-specific methods of compliance with the Privacy Rule andthe extent to which such strategies were successful. Results. The previously conducted observational study included collection of data from a total of 66 EMS agencies (range of 1–37 per site). Data collection from EMS providers was complicated by the lack of a systematic approval mechanism for the research use of EMS records andby incomplete resuscitation records. Agencies approached for approval to release EMS data for study purposes included Department of Health Institutional Review Boards, Fire Commissioners, andCommissioners of Health. The observational study included collection of data from a total of 164 receiving hospitals (range of 1–63 per site). Data collection from receiving hospitals was complicated by the varying requirements of receiving hospitals for the release of patient survival data. Conclusions. Obtaining complete EMS andhospital data is challenging but is vital to the conduct of prehospital research. Obtaining approval from city or state level IRBs or Privacy Boards may help optimize data collection. Uniformity of methods to adhere to regulatory requirements would ease the conduct of prehospital research.

HIPAA Privacy andSecurity Implications for Field Triage

The Health Insurance Portability andAccountability Act (HIPAA) of 1996 addresses insurance reforms, medical savings accounts, fraud andabuse provisions, andhealth information standards. This report discusses HIPAA issues that could impact field triage andemergency medical services.

Impact of institutional review board practice variation on observational health services research.

To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

The new HIPAA (Health Insurance Portability and Accountability Act of 1996) Medical Privacy Rule: help or hindrance for clinical research?

This article was prepared and accepted in 2002. The Federal Policy for Protection of Human Research Subjects, adopted by 17 federal agencies as a common regulatory framework (the “Common Rule”) for most federally sponsored human subjects research, acknowledges the centrality of privacy and confidentiality to the ethical conduct of research by mandating, both implicitly and explicitly, that institutional review boards (IRBs) address these concerns.1 Regulations adopted by the US Food and Drug Administration (FDA) require IRBs to assess protections for privacy and confidentiality in a similar manner.2 Implicit in the requirement (of both the Common Rule and FDA regulations) that IRBs weigh the risks and benefits of proposed research is the expectation that risks to privacy and confidentiality will be among those the IRB considers. Moreover, both the Common Rule and FDA regulations require IRBs to make an explicit finding that a researcher has proposed adequate protections to minimize the possibility of a breach of privacy or confidentiality and the attendant risk that subjects could suffer embarrassment, stigmatization, or discrimination.3 Despite these regulatory mandates, critics state that the existing system of IRB oversight does not ensure that subjects’ privacy rights are respected fully and their confidentiality protected adequately. It is argued that heavily burdened IRBs, particularly those in academic settings, may devote insufficient attention to, and may lack the expertise to evaluate, risks to privacy and confidentiality in an electronic age in which barriers to data transmission are low and in which data stripped of names and other facial identifiers may yet be re-identified for questionable purposes through the use of computer algorithms and diverse databases publicly available from private and governmental sources.4 Claims that some commercially sponsored research may be little more than thinly disguised marketing have further heightened anxiety about an erosion of health …