ParadigmHTM Podcast

Medical imaging is a crucial component of healthcare, encompassing various techniques that provide essential insights into the body's internal structures and functions for accurate diagnosis and treatment. Government agencies like the FDA and NRC, along with accreditation bodies such as The Joint Commission and ACR, rigorously regulate medical imaging practices to ensure patient safety and high-qu...

HIPAA, the Health Insurance Portability and Accountability Act, enacted in 1996, safeguards sensitive health data through the Privacy and Security Rules. The Privacy Rule establishes national standards for protecting health information, while the Security Rule ensures the security of electronic protected health information (ePHI). Compliance with HIPAA is essential for healthcare entities, encompa...

A Quality Management System (QMS) is a structured framework organizations use to manage and improve the quality of their products, services, and processes, ensuring customer satisfaction, continuous improvement, and regulatory compliance. Key elements encompass policies, procedures, risk-based approaches, documentation, resource management, monitoring, measurement, and continuous improvement. ISO...

The National Fire Protection Association (NFPA) is a nonprofit organization established in 1896, committed to promoting fire safety through comprehensive codes, standards, research, and educational programs. In healthcare, the NFPA establishes guidelines for fire protection and life safety in various settings, including hospitals. They also provide specific requirements for medical equipment elect...

The Medical Equipment Management Plan (MEMP) is a comprehensive strategy designed to ensure the safe and effective management of medical equipment in healthcare facilities. It includes processes for equipment acquisition, maintenance, testing, and disposal to meet quality and safety standards. The MEMP can vary between accreditation organizations like The Joint Commission and DNV GL Healthcare due...

Hospital accreditation is vital to ensuring safe and high-quality care. In the U.S., the "big three" accrediting organizations are The Joint Commission, DNV, and HFAP (now part of ACHC). They conduct comprehensive surveys to assess compliance with standards. Deemed organizations are accredited by CMS-approved entities, allowing them to meet Medicare and Medicaid requirements without direct CMS sur...

The United States has two federal health insurance programs, Medicare and Medicaid, which cater to specific groups like the elderly, individuals with disabilities, and those in need of renal dialysis or transplantation. Compliance with minimum health and safety standards mandated by the Social Security Act is necessary for providers and suppliers to participate in these programs. CMS (Centers for...

The FDA's oversight is crucial as it covers various aspects of the medical device industry, including the path to market, post-market surveillance, device recalls, and key definitions. Medical devices are categorized into Class I, II, and III, with each class subject to different levels of regulation. HTM professionals in healthcare organizations play an essential role in ensuring compliance with...

Understanding the total cost of ownership is necessary in evaluating technology but the expenses are just one piece of the return on investment equation. You need to look at the revenue and expenses, and be clear on you financial assumptions.

If you are assessing healthcare technology for purchase or investment you not only have to consider the technical aspects but also the financial aspects of the technology. Total cost of ownership is not just a purchase price. You can't buy a car and never put gas in it. (I know... unless you have an electric vehicle, but don't mess with my metaphor)

Learn how to to review clinical research with a critical eye and also find out more about my habit of drinking too much soda.

Continuation of the determination and validating of "real science", we now take a deeper dive into clinical research methodologies.

Last episode we covered gold standard comparisons of measurements devices. Now lets talk about gold standard comparisons of screening devices. We will touch on the ever-confusion terms of sensitivity and specificity through an illustration about... what else... fishing!

To properly assess clinical technology it is often required to evaluate the technology against a know gold standard. This must be done in a thoughtful and systematic way. This episode touches on gold standard comparisons of measurement devices and briefly introduces concepts in validate you data and draw proper conclusions.

When evaluating or assessing healthcare technology you have to first validate that the science behind the technology is "real". Does it solve a real clinical problem? Is it based on real scientific principles?

Having a comprehensive life cycle plan for your healthcare technology is a good start. But you also need a systematic process to implement that plan and guide your decisions. New investments and growth are important but don't forget about your routine replacements before its too late. You need to have method to this madness we call life cycle planning.

Support, maintenance, and utilizations of healthcare technology is only part of the overall HTM financial picture. The overall life cycle plan takes into consideration to ongoing expenses of you technology as well as the potential impact of future capital purchases. We can't just look at individual equipment decisions. We have to look at the full picture as these financial decisions are competing...

Stop me if you've heard this one... Three physicians walk into a board room...

Contract terms can get complicated and messy. Many of us have not gone through law school so we rely on those with legal training to ponder the language but we still have a responsibility to understand enough to assure the contract language reflects our intended deliverables and supports our current and future service strategies.

Contracts are governing documents that not only define service strategies, organizational liabilities, response guarantees, but are also the source document for many of the financial and business arrangements in HTM. This episode gets you started and the next episode picks up from there.

Financial management for HTM is highly dependent of an understanding of the technical, operational, and regulatory considerations for the medical devices and systems. Therefore, a basic introduction on HTM Service Management options and strategies is essential.

Medical equipment management, whether it is viewed from the perspective of a healthcare delivery organization, medical device manufacturer, or independent service organizations, is grounded in a complex framework of regulations, standards, and best practices. It is important to understand these foundational rules in order to grasp a deep understanding of why the medical device industry operates th...

Healthcare Technology Management budgets have some distinct characteristics however the basic finance, accounting, and budget principles are they same. We will look at the HTM budget from two perspectives. The first is the basic budget outline for an HTM department and the second is the basic budget outline for an HTM services program. You will see later that these have significant overlap and int...

The general ledger is the “log book” for all financial transactions in a business. In Healthcare Technology Management (HTM), many of these transactions are a result of purchasing activities associate with the HTM supply chain. The basic financial statements, such as income and cashflow statements, can summarize and describe these transactions in a way that helps the business assess the effectiven...

A familiarity with basic financial and accounting concepts will help build an understanding of how Healthcare Technology Management (HTM) operations contribute to business decisions or how business decisions drive HTM operations. In order to contribute to the short term or long term financial goals for a healthcare technology business (ie hospital or service provider) it is necessary to link HTM o...