Coastal Carolina University

The HHS Office for Civil Rights on Friday said it has settled nearly a dozen investigations of allegations of HIPAA Right of Access Initiative violations. WHY IT MATTERS OCR's enforcement actions, which include some substantial monetary penalties for the following healthcare providers, and compelled them to furnish patients with timely copies of their health records: Peoria and Canton, Illinois-based ACPM Podiatry , failed to provide a former patient with his requested medical records, according to OCR. In response to an initial complaint, OCR provided ACPM with written technical assistance regarding the Privacy Rule’s right of access standard and closed the matter. OCR received a second complaint from the same individual, alleging that ACPM still had not provided the medical records, after numerous requests. ACPM did not respond to multiple data requests from OCR, nor to OCR’s Letter of Opportunity and Notice of Proposed Determination. OCR issued a Notice of Final Determination and imposed a civil money penalty of $100,000. Associated Retina Specialists , of New York, failed to provide a patient with a copy of her medical records until three days after OCR initiated its investigation, and nearly five months after the complainant’s first written request. The practice agreed to take corrective actions and paid $22,500 to settle a potential violation of the HIPAA Privacy Rule right of access standard. Baltimore-based Lawrence Bell, Jr., D.D.S ., a dental practice, failed to provide timely access to a patient’s medical record, according to OCR. The dental practice has agreed to take corrective actions and has paid $5,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. Ormond Beach, Florida-based Coastal Ear, Nose, and Throat allegedly failed to provide timely access to medical records after multiple requests for such records from a patient. Coastal ENT has agreed to take corrective actions and has paid $20,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard Danbury Psychiatric Consultants , located in Massachusetts, failed to respond timely to a complainant’s access request. DPC also withheld the complainant’s access on the basis that the complainant had an outstanding balance and required a signed request or authorization request. DPC has agreed to take corrective actions and has paid $3500 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. Erie County Medical Center Corporation , a public benefit corporation that operates a hospital, Erie County Medical Center, located in Buffalo, New York, failed to timely provide an individual with a complete copy of his medical records. ECMC has agreed to take corrective actions and has paid $50,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access standard. Fallbrook Family Health Center , located in Nebraska, failed to provide timely access to medical records. Fallbrook Family Health Center has agreed to take corrective actions and has paid $30,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access standard. Hillcrest Nursing and Rehabilitation , located in Massachusetts, failed to provide an individual’s personal representative with timely access to her son’s medical records. Hillcrest has agreed to take corrective actions and has paid $55,000 to settle a violation of the HIPAA Privacy Rule’s right of access standard. MelroseWakefield Healthcare , a provider in Massachusetts, did not provide a personal representative with timely access to medical records on the mistaken basis that the durable power of attorney in this instance did not allow for the provision of such medical records. MWH has agreed to take corrective actions and has paid $55,000 to settle a violation of the HIPAA Privacy Rule’s right of access standard. Memorial Hermann Health System , a not-for-profit health system in Southeast Texas, consisting of 17 hospitals, including Memorial Hermann Katy Hospital, failed to respond timely to a complainant’s access request. Memorial Hermann has agreed to corrective actions and has paid $240,000 to settle a potential violation of the HIPAA Privacy Rule's right of access standard. Southwest Surgical Associates is a group practice with nine locations in the Greater Houston, TX area, failed to provide an individual timely access to their health information. SWSA has agreed to corrective actions and has paid $65,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access standard. THE LARGER TREND The 11 new cases bring the total number of settlements to 38 since OCR began enforcing the HIPAA Right of Access Rule in 2019 . Read about some of those recent enforcement actions here , here and here . Despite the more rigorous enforcement, however, some patients are still forced to sue to gain access to their own healthcare information. ON THE RECORD "It should not take a federal investigation before a HIPAA covered entity provides patients, or their personal representatives, with access to their medical records,” said OCR Director Lisa J. Pino in a statement. "Health care organizations should take note that there are now 38 enforcement actions in our Right of Access Initiative and understand that OCR is serious about upholding the law and peoples’ fundamental right to timely access to their medical records."

Quantitative biomarkers of demyelination can improve clinical trial design and accelerate development of disease-modifying therapeutics SAN FRANCISCO, July 14, 2022 /PRNewswire/ -- Rune Labs, a precision neurology software and data platform company, today announced it is enrolling patients with multiple sclerosis (MS) in a study to identify neurophysiological biomarkers of the disease. The company has partnered with Coastal Research Institute (CRI) to measure demyelination in patients with spinal cord stimulators using closed loop technology. Demyelination is a hallmark symptom of MS that occurs when the immune system attacks nerve fibers, causing lesions in the brain and spine. More remyelination therapeutics are entering the clinic, but there are no biomarkers that measure a patient's degree of myelination, making it difficult to assess a drug's efficacy. Clinical scores currently used as endpoints and screeners in trials are imprecise and do not always correlate with lesion activity. Other approaches like imaging and measuring optic nerve electrophysiology only apply to a subset of patients with specific symptoms. "By taking advantage of access to the spinal cord provided during routine clinical procedures, this study will capture precise neurophysiological data and measure myelination using a variety of evoked potentials," said Ro'ee Gilron, Rune Labs' lead neuroscientist. "Rune's AI platform enables us to take raw brain data and convert it into actionable biomarkers of myelination." With today's study, Rune Labs and CRI aim to develop a MS metric that is sensitive to the degree of myelination and can be used to augment a clinical score. The partners are enrolling MS patients who will receive a spinal cord stimulator, a common implant to reduce neuropathic pain. Rune Labs will be able to record electrophysiological signals from the spinal cord and cortex, measuring the underlying physiology tied to myelination. Clinical metrics of MS severity (EDSS) used today are non-linear, fluctuate widely at lower levels, are stagnant at higher scores, and mostly focus on mobility metrics. The partners are developing a more sensitive metric to better capture the heterogeneity of MS presentation. "Currently, clinicians have no easy way to measure myelination in patients with multiple sclerosis," said Krishnan Chakravarthy, MD, PhD, CRI Co-Founder and Executive Director, and adjunct faculty of UCSD Center for Nanoengineering. "If we're going to develop effective disease-modifying therapies, and design and run more efficient clinical trials that capture efficacy signals, we'll need precise, non-invasive biomarkers that measure the degree of myelination and reflect disease pathology." Rune Labs' first-in-class precision neurology software platform uses machine learning to capture and analyze electrophysiological brain data to uncover previously overlooked markers of disease. This provides researchers and drug developers with novel biomarkers to design more efficient clinical trials and develop better-targeted therapies. About Rune Labs Rune Labs is a software and data analytics company for precision neurology, supporting care delivery and therapy development. StrivePD is the company's care delivery ecosystem for Parkinson's disease, enabling patients and clinicians to better manage Parkinson's by providing access to curated dashboards summarizing a range of patient data sources, and by connecting patients to clinical trials. For therapeutics development, biopharma and medical device companies leverage Rune's technology, network of engaged clinicians and patients, and large longitudinal real-world datasets to expedite development programs. The company has received financial backing from leading investors such as Eclipse Ventures, DigiTx, TruVenturo and Moment Ventures. For more information, please visit . About Coastal Research Institute (CRI) Coastal Research Institute was founded to foster clinical and research excellence worldwide. With partners both in the US and Australia the Institute founded by physicians focuses on clinical research excellence that includes site training, quality data collection, timely clinical study completion and research excellence in new technology development as well as clinical trials in the device and pharmaceutical specialties. A multidisciplinary and diverse leadership enables services that include study design, execution, data analysis, and publication. The institute continues to contribute to the global discourse in the field of neuroscience and pain medicine and is a leading premiere research institute in Southern California. Media contacts: Consort Partners for Rune Labs [email protected] SOURCE Rune Labs

– The B-SIMPLE4 pivotal Phase 3 clinical study of berdazimer gel, 10.3% (SB206) is the largest interventional trial of molluscum contagiosum ("molluscum") (n=891)1 – – Company previously reported positive topline efficacy and favorable safety data at Week 12 from B-SIMPLE 4 in June 2021, achieving statistical significance for the primary endpoint with p-value less than 0.0001 and no serious adverse events related to treatment with berdazimer gel, 10.3% – – There are currently no FDA approved prescription therapies available for the treatment of molluscum, a viral skin infection that impacts as many as 6 million people each year, mostly children2,3 – DURHAM, N.C., July 13, 2022 /PRNewswire/ -- Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), announced today the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology.1 Berdazimer gel, 10.3%, Novan's potential first-in-class topical nitric oxide-based prescription treatment, demonstrated favorable efficacy and safety. "Results from the B-SIMPLE 4 clinical study strongly demonstrate the promise of berdazimer gel, 10.3% as a potential first and only prescription medication for molluscum. The ability for the patient/caregiver to apply a nitric oxide-releasing topical gel to lesions that facilitates complete clearance is a breakthrough in molluscum treatment since many go untreated due to limited options. These study results also showed favorable tolerability which is a key factor in treating children," said Adelaide Herbert, M.D., Chief of Pediatric Dermatology at McGovern School of Medicine and Children's Memorial Hermann Hospital. Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4, was a multicenter, vehicle-controlled, double-blind study, which enrolled 891 patients across 55 clinics in the United States that were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions as compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema. Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of berdazimer gel, 10.3% achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of vehicle patients. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a ≥90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients. "If approved, berdazimer gel 10.3% could offer pediatricians a way to initiate molluscum treatment with a topical prescription. Unlike current molluscum treatments, like cantheradin or curettage, which often require more than one in-office application, berdazimer could provide molluscum patients or their caregivers the ease of self-applying the gel on the lesions," said Stephan W. Stripling, MD, Co-Medical Director, Coastal Pediatric Research, Charleston, SC. In June 2021, Novan reported a statistically significant greater treatment effect as compared to vehicle for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12. Overall, berdazimer gel, 10.3% was well tolerated with low discontinuation rates due to adverse events. Although treatment-emergent adverse events (TEAS) were numerically higher in those receiving berdazimer gel, 10.3%, the majority were mild in severity. Local skin reactions (LSRs) were absent in >92% of all patients, except for erythema (redness), which was the most frequently observed LSR in berdazimer gel, 10.3% patients and mostly mild to moderate. Study patients did not exhibit keloid or hypertrophic scars following treatment. "Novan is proud to have conducted the largest molluscum interventional trial and to have achieved the results we did. If approved, berdazimer gel, 10.3% could be the first FDA-approved prescription product for the treatment of this highly contagious viral skin infection that mostly affects children. We are continuing our preparations to submit a New Drug Application for berdazimer gel, 10.3% and remain on target to do so before the end of 2022," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that if approved, topical berdazimer gel, 10.3% as a prescription, self- or caregiver-applied therapy would satisfy an important patient care need for the treatment of molluscum. About Berdazimer Berdazimer (sodium), the active ingredient in berdazimer gel, 10.3%, is a new chemical entity. Berdazimer gel, 10.3% is a potential first-in-class topical nitric oxide-releasing agent in Phase 3 development for the treatment of molluscum contagiosum (SB206). Berdazimer gel, 3.4% (SB204), a topical monotherapy in Phase 3 clinical development for the treatment of acne, utilizes the same active ingredient as berdazimer gel, 10.3% and is formulated specifically to address acne. About Molluscum Molluscum contagiosum is a common, contagious viral skin infection caused by the molluscipoxvirus,4 affecting approximately six million people in the U.S. annually2,3, with the greatest incidence in children aged one to 14 years.5 Infected children typically present with 10 to 30 unsightly lesions,6 and, in severe cases, they can have around 100 lesions.7 mostly clustering on the face, trunk, limbs and axillary areas.6 Over 70% of molluscum patients go untreated.8,9 There are no U.S. Food and Drug Administration ("FDA") approved therapies for molluscum, with current treatments limited to potentially painful in-office, healthcare provider-administered physical procedures or cantharidin, or off-label prescriptions and over-the-counter products.6,10 Molluscum may take a long time to resolve, with lesions persisting 13 months to 5 years10,11 and transmission of this highly-contagious virus is common, spreading to other children through direct skin contact or sharing contaminated objects like towels.12 In-household transmission to other children is reported around 41%.11 Despite the prevalence and high transmissibility, there is a significant unmet need in the molluscum treatment landscape. About Novan Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates where there are unmet medical needs. We are developing SB206 (berdazimer gel, 10.3%) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum. Novan recently completed the acquisition of EPI Health. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, the company employs approximately 100 staff, including sales personnel currently covering 42 territories, and promotes products for plaque psoriasis, rosacea, acne and dermatoses. Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates, such as berdazimer gel, 10.3% (SB206) for molluscum contagiosum, and the potential benefits of berdazimer gel, 10.3%, if approved. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products risks and uncertainties in the Company's ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company's product candidates; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company's product candidates; the Company's reliance on arrangements with third parties to support its operations and its development and manufacturing efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2021, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. References: Browning J, Enloe C, Cartwright, M. Hebert A, Paller A, Hebert D, Kowalewski E, Maeda-Chubachi T. Efficacy and safety of berdazimer 10.3%, a nitric oxide-releasing topical gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Derm. 2022. Epub ahead of print. July 13, 2022. LINK About Molluscum. Accessed July 12, 2022. Global molluscum contagiosum epidemiology forecast to 2028 December 16, 2019. Accessed July 12, 2022 Chen X, Anstey AV, Bugert JJ. Molluscum contagiosum virus infection. Lancet Infect Dis. 2013;13(10):877-888. Schofield JK, Fleming D, Grindlay D, Williams H. Skin conditions are the commonest new reason people present to general practitioners in England and Wales. Br J Dermatol. 2011;165(5):1044-1050. doi:10.1111/j.1365-2133.2011.10464.x Badri T, Gandhi GR. Molluscum Contagiosum. [Updated 2022 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: Accessed July 10, 2022. Viral Diseases. In: James, William D ed. Andrews' Diseases of the Skin. 13th edition. London, UK: Elsevier; 2020: 362-420.e8 Syneos. Medical and Pharmacy Benefits Claims, Syneos Insights Suite, 2022 Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol. 2015;32(3):353-357. Ong SK, et al. Pediatr Dermatol. 2021;38(5):1400-1403 American Academy of Dermatology. Molluscum contagiosum: Diagnosis and treatment . Accessed July 12, 2022 Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15(2):190-195. Meza-Romero R, Navarrette-Dechent C, Downey C. Molluscum contagiosum: an update and review of new perspectives in etiology, diagnosis, and treatment. Clinical, Cosmetic and Investigational Dermatology. 2019;12:373-81. SOURCE Novan, Inc.