Industry Insider News

Wound Care Researcher
Earns Lifetime Achievement Award
Faith M. Knabe (Faith K. Goldschmidt), MA, MPH, has been recognized by the Continental Who's Who with the 2015-16 Lifetime Achievement award as a result of 50 years of excellence in the field of healthcare. Knabe 's areas of work include the clinical microbiology research areas of wound care and burn care. Now retired, Faith most recently served as research scientist and manager of data evaluation with the New Jersey Department of Health (DOH). She spent almost 25 years with the DOH. Faith was a member and chair of the department's Institutional Review Board (IRB), which oversees all research on human subjects, for almost 10 years. She also spent four years at New Jersey Medical School as a research scientist, coordinator of research projects, and liaison with University of Medicine and Dentistry of New Jersey's IRB. 

As part of her responsibilities, Faith was one of the creators, implementers and administrators of New Jersey's diagnosis-related group (DRG) system of hospital payment that was adopted by Medicare in 1983 as the basis for its Prospective Payment System (PPS). As a unit director, Faith coordinated and managed the tasks of five teams (30 staff members) that ran New Jersey's DRG system (clinical and quality of care, development, certificate of need, financial feasibility and audit, and data teams). Considered an expert on the DRG system, Knabe presented testimony on the system to numerous federal and state committees, and gave many lectures on various aspects of the DRG system. The PPS and various adaptations of it still exist as the federal method of payment for hospitals, federally qualified health centers, home health agencies, etc.

Knabe started her career in healthcare in 1967 as a research scientist in the clinical microbiology section of the research division of Johnson & Johnson.  During her 11-year tenure, she developed, organized, coordinated, and managed projects to test and identify effective, efficient new and existing products for wound care, burn care, and topical therapies. She earned her MA in microbiology from Smith College in 1963 and holds her MPH in general public health from Columbia University’s Mailman School of Public Health (1978). In addition, she received a BA in biology from Clark University in 1962 and is currently a member of the New York Academy of Science, Sigma Xi, the National Association of Professional Women, and Continental Who's Who.

AMA Adopts Principles to Promote
Safe & Effective Mobile Health Apps
During a recent meeting of the American Medical Association (AMA), physicians voted to approve a list of principles to guide coverage and payment policies supporting the use of mobile health (mHealth) apps and associated devices that are accurate, effective, safe, and secure.

Mobile health apps and associated digital health devices, trackers, and sensors can vary greatly in functionality, accuracy, safety, and effectiveness. While physicians are optimistic about digital health innovation and its potential medical benefits, mHealth apps and devices that are not safe can pose threats to the health and safety of patients, officials said. AMA policy acknowledges the need to expand the evidence base necessary to show the accuracy, effectiveness, safety, and security of mHealth apps.

“The new AMA principles aim to foster the integration of digital health innovations into clinical practice by promoting coverage and payment policies that are contingent upon whether mHealth apps and related devices are evidence-based, validated, interoperable, and actionable,” said AMA immediate past president Steven J. Stack, MD. “It is essential for mHealth apps support care delivery that is patient-centered, promotes care coordination, and facilitates team-based communication.”

The AMA’s advocacy promoting coverage, payment, and financial incentive mechanisms will be guided by the following principles to support the use of mHealth apps and associated devices, trackers, and sensors by patients, physicians, and others that:

• Support the establishment or continuation of a valid patient-physician relationship;
• Have a clinical evidence base to support their use in order to ensure mHealth app safety and effectiveness;
• Follow evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care, and positive health outcomes;
• Support care delivery that is patient-centered, promotes care coordination, and facilitates team-based communication;
• Support data portability and interoperability in order to promote care coordination through medical home and accountable care models;
• Abide by state licensure laws as well as state medical practice laws and requirements in which the patient receives services facilitated by the app;
• Require physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services or be providing these services as otherwise authorized by that state’s medical board; and
• Ensure the delivery of any services via the app be consistent with state scope-of-practice laws.

Patient privacy and data security in digital health are also key AMA concerns since mHealth apps and devices can be subject to data breaches that disclose personal health information, officials said. The new AMA policy encourages physicians and the mobile app industry to promote patient awareness of the varying levels of data privacy and security afforded by mHealth apps. To best secure patients’ personal health information, mHealth apps and associated devices, trackers, and sensors must abide by applicable laws addressing privacy and security. According to the new AMA policy, clinicians should consult with qualified legal counsel if they are unsure of whether mHealth apps meet standards required by federal or state privacy and security laws.

Given the lack of regulation of mHealth apps, regardless of whether the apps related device is encrypted, the AMA advises clinicians to alert patients of the potential privacy and security risks for any mHealth apps that they prescribe or recommend, and document the patient’s understanding of such risks. Questions remain regarding liability risks to physicians who use, recommend, or prescribe mHealth apps. Accordingly, the AMA will assess the potential liability risks to physicians for using, recommending, or prescribing mHealth apps, including risk under federal and state medical liability, privacy, and security laws, officials said.

ASPEN Releases New Enteral Nutrition
Safe Practice Recommendations 

The American Society for Parenteral and Enteral Nutrition (ASPEN) has issued updated recommendations for safe practices in enteral nutrition (EN). By providing nutrition directly into the gastrointestinal tract through a feeding tube, EN is a valuable clinical intervention for all ages and in a variety of care settings. Along with its many outcome benefits, however, comes the potential for adverse effects.

“In both the adult and pediatric population, providing nutrition support is essential to promoting improved outcomes,” said Charlene Compher, PhD, RD, CNSC, LDN, FADA, FASPEN, ASPEN president. “ASPEN developed these recommendations to help prevent adverse events, including fatalities, and to help optimize outcomes in the use of EN therapy.”

Building on its 2009 recommendations, ASPEN brings an even greater level of attention to EN safety. In addition, the new set of guidelines are detailed across each step of the process, and for all clinicians involved in caring for patients who receive EN. For the recommendations, click here. https://pen.sagepub.com/content/early/2016/11/09/0148607116673053.full.pdf+html

“The EN process is highly complex and clinical complications can occur at any step,” explained Peggi Guenter, PhD, RN, FAAN, ASPEN’s senior director of clinical practice, quality, and advocacy. “Maximizing the benefits of EN while minimizing adverse events requires a systematic approach to care.”

To promote a culture of safety, ASPEN recommends applying an interdisciplinary approach to incorporating the best practice recommendations. It supports this approach by aligning recommendations across all aspects of the EN therapy process: patient assessment; prescribing and implementation of the treatment plan; review and communication with the nutrition and patient support teams; placement of enteral devices and medication delivery; administration and documentation standardization; monitoring and error reporting protocols; and transition of care.

To develop the recommendations, an interdisciplinary group of ASPEN experts identified key questions related to EN practice issues with safety implications. After grouping the questions into relevant sections, the authors weighed risks against benefits to come to a set of best practice recommendations for each one.

“Safe and effective nutrition is an integral component of care,” said Compher. “Our strong hope is that this information will help clinicians achieve the best nutritional outcomes for their patients.”

Wound Care Company
Receives Investment Funds

Bio Med Sciences Inc., Allentown, PA, a manufacturer of specialized materials for burn and wound care, will receive $25,000 in matching funds to work with Lehigh University's Enterprise Systems Center to complete implementation of a new enterprise resource planning system. The funds will be provided through investments being made by Ben Franklin Technology Partners of Northeastern Pennsylvania, an organization that invests in and supports companies to create and retain highly paid, sustainable jobs, catalyze technology-based economic growth in northeastern Pennsylvania, and advance technologies that improve the human condition. Officials recently announced $671,000 in investments for similar early-stage companies and matching funds for established manufacturers working on innovation projects with institutions of higher education. For more information, click here. www.silon.com/bms_news/meet-mark-dillon-president-bio-med-sciences-alumnus-ben-franklin-technology-partners/