FDA to staff new digital health unit

Editor's Note

The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports.

The FDA intends to build a group of experts who are experienced with software lifecycle management, mobile medical apps, medical device interoperability, cybersecurity, digital health product development, and machine learning.

Responsibilities of the group will include developing and implementing regulatory policy, identifying modifications to premarket and postmarket reviews of digital health products, and providing training on new regulations and procedures.

The FDA has officially kicked off a hiring process to fill more than a dozen positions within the agency's new digital health unit. The government's job board lists two open positions for "interdisciplinary engineer" that will help develop and implement new policies for regulating innovative health devices.

Register now by completing the form below. Following the webinar, you will be able to take an evaluation and receive 1 CE

A High-Reliability Organization (HRO) is an organization that experiences fewer accidents or events of harm than otherwise anticipated, despite operating in a complicated and risky environment. Many healthcare organizations aspire to become HROs.

Periop teams play an essential role in advocating and implementing the HRO agenda. Applying HRO principles to daily functions in the operating room is a way to safeguard patient safety, even during moments of considerable change or disruption in the surgical suite.

This session offers a blueprint for periop staff desiring to integrate high reliability principles into their workflows. Our clinical nursing experts will review each of the five foundational principles of HROs. They’ll provide strategies and examples as to how each principle can be applied within the OR to impact care in a positive way.

Aileen R. Killen, RN, PhD, CPPS is the Director, Perioperative Excellence at LiveData. In her role, she collaborates with LiveData on strategies for adoption and utilization of PeriOp Manager, a surgical workflow solution. In addition to holding perioperative leadership positions in some of the country’s leading medical facilities, including New York University Medical Center, The Hospital for Special Surgery, Memorial Sloan Kettering Cancer Center, and Dartmouth-Hitchcock Medical Center, Aileen was also heavily involved in the patient safety arena as an AHA-NPSF Patient Safety Leadership Fellow, where she focused on designing operating rooms for patient and staff safety.

Jeffrey Oliver, Lt Col, Ret., CCNS, CNOR has over 30 years of nursing experience and has served in a variety of nursing roles throughout his career. He was commissioned in the United States Air Force in 1995. He was deployed three times during his twenty-five-year career. Jeff was assigned as faculty at the Uniformed Services University Graduate School of Nursing and served as the Perioperative Nursing Consultant to the Air Force Surgeon General before retiring from the Air Force in March 2021. Jeff then served as the Director of Surgical Services at a community hospital in South Carolina before joining LiveData as a Clinical Support Specialist.

Register now by completing the form below. Following the webinar, you will be able to take an evaluation and receive 1 CE

Now more than ever, it’s crucial for health systems to maximize utilization of their highest-value assets. Shrinking margins and staff scarcity have changed the way hospitals and ASCs look at their Operating Room block allocation. Wasted block time can threaten the financial viability of a department, and turning around an inefficient OR requires a purposeful, data-driven approach.

Leaders at Northwest Specialty Hospital identified the need for a Block Optimization solution, but their first partnership ended with disappointment and frustration. Rather than give up on the idea, they decided to try a new approach and were able to achieve their goals through meaningful collaboration.

In this webinar, we’ll speak to JJ Turbin, Executive Director of Finance, about what he learned from the experience and how he persevered to find a solution that fit Northwest’s needs.

Learning Objectives:

• Identify the most impactful effects of predicting and tracking surgical block utilization
• Discuss the value of collaboration when adopting a block optimization solution
• Build an evaluation framework to measure success when implementing a new block management process

Speaker:

JJ Turbin is an Executive Director of Finance at Northwestern Specialty Hospital. With over 10 years of experience in healthcare finance, JJ currently serves as the Executive Director of Finance at Northwest Specialty Hospital, overseeing accounting, treasury, and accounts payable teams. He provides strategic financial leadership, focusing on month-end close processes, forecasting, and financial analysis to drive hospital performance.

His career includes roles as a Senior Financial Analyst, where he managed P&L analysis, contract negotiations, and profitability assessments, and as Quality Assurance Manager, where he led compliance and safety initiatives. He is passionate about leveraging data to optimize operations and improve patient care.

He holds an MBA in Healthcare Management and a Bachelor’s degree in Communications.

Register now by completing the form below. Following the webinar, you will be able to take an evaluation and receive 1 CE.

In this encore presentation of LiveData’s seminar at the OR Manager Conference, LiveData Clinical Support Specialist Jeffrey Oliver, Lt. Col, Ret., CCNS, CNOR, will explain how a medical center in the southeastern US increased their OR throughput after widespread pandemic slowdowns.

By deploying analytics-driven insights, the hospital found where workflow updates would most impact OR capacity. While the medical center was able to increase capacity to schedule more patients and eliminate wait times, this led to a new challenge: with over a dozen hospitals and ASCs nearby, local practices held out for visible scheduling improvements before filling the hospital’s newly-created capacity.

This condensed session will explain in detail how focusing on six metrics was the most effective way for the hospital to attract new cases, resulting in a 6% growth in case volume.

Learning objectives:

• Understand why six metrics had an outsized impact on OR capacity
• Identify practical analytic methods to track these six key indicators
• Summarize how a comprehensive OR scheduling policy and governance structure can address the six key metrics at an institutional and individual level

Speaker:

Jeffrey Oliver, Lt Col, Ret., is a Clinical Nurse Specialist (CCNS) and certified perioperative nurse (CNOR). He has over 30 years of nursing experience and has served in a variety of nursing roles throughout his career. He was commissioned in the United States Air Force in 1995. He was deployed three times during his twenty-five-year career. Jeff was assigned as faculty at the Uniformed Services University Graduate School of Nursing and served as the Perioperative Nursing Consultant to the Air Force Surgeon General before retiring from the Air Force in March 2021. Jeff then served as the Director of Surgical Services at a community hospital in South Carolina before joining LiveData as a Clinical Support Specialist.

Register now by completing the form below. Following the webinar, you will be able to take an evaluation and receive 1 CE.

In response to rising healthcare demands, hospitals seek to enhance service delivery without costly expansions. This presentation showcases WakeMed Health’s innovative approach to ensuring access and optimizing their capacity within their operating rooms and procedural rooms.

Dr. Charles Harr, CMO at WakeMed, will demonstrate the crucial role of physician and anesthesia leader involvement in optimizing both operating room and procedural area utilization. He will share insights on how they leveraged innovative capacity optimization technologies and transformation services in conjunction with their EHR systems, highlighting real-world benefits and cost savings achieved through these strategic improvements including:

• 11% increase in prime-time case minutes across their operating rooms
• 21% increase in prime-time case minutes within their procedural areas
• Reaching an system high in proactively released block minutes, increasing 13.5% year-over-year

Learn how WakeMed’s approach minimized waste, maximized high-value resources, and led to significant operational efficiencies and financial gains. This session offers a blueprint for healthcare organizations seeking to optimize their most valuable resources in today’s challenging environment.

Learning Objectives:

• Examine the role of physician and anesthesia leaders in implementing proactive access and capacity management strategies to optimize OR and procedural room utilization.
• Evaluate the benefits of integrating capacity management technologies and services with existing EHR systems to enhance hospital operational efficiency.
• Analyze how strategic improvements in capacity management can lead to substantial cost savings through minimized resource waste and maximized utilization of expensive equipment and procedural areas.

Speaker:

Charles D. Harr, MD, MBA
Rear Admiral, MC, SHCE (Ret.)
CMO / Executive Healthcare Strategist

Dr. Harr has more than 25 years of healthcare experience in commercial and military healthcare across various levels of care – including acute, ambulatory, sub-acute, behavioral and long-term – as well as payers. Dr. Harr is a savvy and dedicated healthcare executive committed to optimizing organizational performance, delivering leading-edge care, and generating exceptional, cost-effective results. He is an accomplished Cardiovascular and Thoracic Surgeon with a reputation as a leading physician in the field of minimally invasive robotic techniques. He established an exceptional program ranked #2 in volume in the Mid-Atlantic Region and #18 in the United States. Dr. Harr is an avid proponent of advances in medicine and healthcare. He has led numerous initiatives and innovative solutions that consistently improve quality of care and patient outcomes. As the lead clinical physician and skilled educator, he employed state-of-the-art innovations in healthcare and evidence-based practices to provide general surgery residents with outstanding thoracic surgical training at a nationally ranked healthcare facility. He is known as a results-focused and resourceful visionary who advocates lifelong learning.

Registration form

Register now by completing the form below. Following the webinar, you will be able to take an evaluation and receive 1 CE.

In an era of rapid technological advancement, surgical teams must leverage cutting-edge tools and practices to enhance patient care and operational efficiency while navigating the challenges of electronic health records. This webinar explores essential technologies for modern Oracle Health Cerner-based surgical teams, focusing on Software as a Service (SaaS) solutions and cybersecurity measures in healthcare settings.

We’ll examine how cloud-based SaaS platforms optimize surgical capacity, increase case volume, and boost surgeon and staff satisfaction in resource-constrained environments. The webinar will cover critical aspects of successful surgical scheduling, including planning, team communication, patient safety, and data management. Given the sensitive nature of medical information, we’ll also address the latest cybersecurity threats facing healthcare institutions and provide an overview of best practices for protecting patient data and maintaining HIPAA compliance. Key topics will include secure data storage, encryption methods, and staff training for cybersecurity awareness.

Learning Objectives

1. Identify and evaluate key technologies that dramatically increase the value delivered by Oracle Health Cerner by offloading key surgical workflows to a dedicated System of Engagement, focusing on the potential to increase case volumes, improve patient outcomes, and boost operational efficiency.
2. Analyze how an advanced System of Engagement complements electronic health records (EHRs) to boost accessibility, efficiency, security, and patient safety in surgical settings.
3. Recognize common cybersecurity threats in healthcare and implement effective strategies to protect patient data and maintain HIPAA compliance.

Speakers:

Michael Foster
Independent Healthcare IT Consultant
Mike Foster has worked in IT for 30 years and Healthcare IT for 20 years. His experience includes stints with multiple companies, including Perot Systems, Dell, NTT Data, and Tenet, as well as providing consulting for multiple companies in the healthcare space. Mike specializes in field service operations and has extensive knowledge of PACS/Radiology, EMR, and other specialty systems, including security systems, phones, and overall healthcare operations. Mike has completed large builds as an IT PM liaison, building a new 250,000-square-foot hospital and opening more than 40 physician clinics. Mike is well-versed in HIPAA. He is a FEMA HazMat Instructor and a CPI Certified Crisis Prevention Instructor. He is also a certified webmaster and holds an A+ CompTIA certification.

Matthew Churchill
Chief Operating Officer
LiveData
Matt brings LiveData a combined clinical and healthcare sales background that focuses on delivering solutions to meet each customer’s needs and preferences. Matt began his career as a licensed physical therapist, earning his B.S. in Physical Therapy from the University of Connecticut. He then transitioned into a successful sales career in both the pharmaceutical and medical device industries, winning several performance awards.

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Mastering OR Renovations and New Builds – Working with Your Team to Navigate Design Challenges and Achieve Superior Results

Preparing for an OR renovation or new build project? You may be asking yourself – where should I begin?

The OR Manager Construction-Renovation Webinar Series will serve as your blueprint to tackle the most daunting, but exciting projects in your career.  This webinar will answer some of your most pressing questions, including:

• Who should be part of your project team and when should they be involved?
• How do I make sure the design resolves my current issues?
• How do you go about designing a new OR suite working within the square footage you have?
• Do you need an infection control risk assessment?
• How do I link in the AORN design and maintenance guidelines into my process?
• What else do I need to know?

These are just some of the considerations to approaching an OR renovation or new build project. 

Join OR Manager in this 3-part complimentary webinar series as we explore real-world experiences and hear from professional experts to help you navigate your journey through design and beyond. Each session is approved for 1 CE contact hour.

• Part 1 – Pre-Design and Schematic Design Planning Phase – The focus will be on strategic planning, identifying project needs, ROI justification, due diligence, and team formation. In addition, we will explore the process for developing floor plans and translating the vision into a design concept. 
  
• Part 2 – Detailed Design Development Phase – The focus will be on the details and placement of specific items within each operating room – from medical equipment to furniture to information technology items to supplies. This phase will also detail the process improvement opportunity for front-line staff to become more involved on any pain points and workarounds.

• Part 3 – Construction and Activation Phase – The final session will explain your role during the construction phase and identify the required final activities prior to performing your first procedure. As a wrap up, details on the capital planning process will be shared along with best practices from the pre-design to construction phase linking in the AORN guidelines for design and maintenance of the surgical suite.

 Who should attend:

OR Managers, Directors, Executive Directors, C-Suite and other Perioperative Leadership.

Learning objectives: 

• Recognize who should be part of your project team to give input on the design.
• Understand the various phases of the design and construction process, your role in each, and how to maximize your opportunity for success.
• Gain an understanding of the capital planning process and how the AORN guidelines for design and maintenance of the surgical suite should be linked into this process

Part 1 – Building the Blueprint: Where Do I Begin?
Thursday, March 28
12:00 PM – 1:00 PM Eastern

Join us for Part 1 of OR Manager’s Construction-Renovation webinar series as we delve into the foundational aspects of OR renovation and design planning starting with the pre-design and schematic design planning phase – Building the Blueprint: Where Do I Begin?

The pre-design and schematic design planning phase of an operating room renovation/construction project is critical for laying the groundwork for success. In this webinar, we will explore the strategic planning steps from establishing a comprehensive timeline, to ROI justification, to translating the vision into tangible design concepts. We will delve into the intricacies of crafting schematic designs with a specific focus on floor plans and room arrangements. Through case studies and best practices, attendees will gain insights into how to work with your design team in developing plans that meet the overarching vision of the project.

• Understand the components of the pre-design and schematic design planning phase.
• Gain knowledge on when to engage key stakeholders in the planning.
• Understand the process that will allow you to translate the vision into a design concept.

Part 2 – Detailed Design Development Phase: It’s All in the Details – Optimizing Workflow and Staff Engagement

Wednesday, April 10
12:00 PM – 1:00 PM Eastern

Join us for Part 2 of OR Manager’s Construction-Renovation webinar series as we delve into the finer details of design plans to optimize efficiencies while engaging front line staff.

The detailed design development phase of operating room projects marks a pivotal stage where attention shifts to the precise placement of essential items, from medical equipment to furniture to information technology components and supplies. This webinar will explore the intricacies of orchestrating detailed design development in OR projects, emphasizing the importance of optimizing item placement to enhance workflow efficiency and patient care. Additionally, participants will discover how this phase presents an opportunity for frontline staff to actively engage in process improvement initiatives, identifying pain points and workarounds to streamline operations and elevate the quality of patient care.

Learning objectives:

• Understand the significance of detailed design development.
• Discuss optimal equipment placement and workflow efficiency.
• Empower frontline staff and engage them in the design process.

Part 3 – Construction and Activation Phase: Navigating Operating Room Construction and Renovation – From Blueprint to Reality

Thursday, April 25
12:00 PM – 1:00 PM Eastern

Join us for Part 3 of OR Manager’s Construction-Renovation webinar series as we embark on the final stage of your OR project.

The construction and activation phase of the operating room represents the culmination of meticulous planning and execution, where the vision transforms into tangible reality. In this final webinar, we will explore the intricacies of the construction and activation phase, focusing on the collaborative efforts between key stakeholders to bring the project to fruition. Participants will also gain insights into the detailed work that goes into obtaining capital approvals, creating comprehensive documents to guide construction activities and finalizing budgets. In addition, this webinar will examine best practices, lessons learned and provide take-home tools for anyone who’s about to embark on an OR construction/renovation project.

Learning objectives:

• Discuss the role of comprehensive documentation in the construction journey.
• Explore detailed capital approval strategies.
• Examine best practices and key takeaways from the pre-design to construction phase.
• Gain an understanding of how the AORN guidelines for design and maintenance of the surgical suite should be linked into this process.