Category: Blog

A new bill, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, has been introduced by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), with the aim to exempt low-risk medical software and mobile medical apps from regulation by the U.S. Food and Drug Administration. It was officially was introduced to Congress Dec. 4, 2014.

According to FierceHealthIT, the bill has been introduced as the “the beginning of a conversation” on the issue of health IT regulation. The bill will be re-introduced in January if it doesn’t move throughout the remainder of the 2014 lame duck session.

“Our bill attempts to create specific legal definitions around types of software to exempt them from FDA regulation,” Hatch told FierceHealthIT. “Specifically, the bill limits and clarifies the FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records and software that aids healthcare providers in developing treatment recommendations for their patients.”
Hatch also said his bill, in conjunction with a repeal of the medical device tax, is important to protecting and enabling innovation in healthcare. “Since the tax took effect last year, it has been a drain on American innovation, job growth and our ability to provide groundbreaking medical technologies to patients in need,” he told FierceHealthIT.

According to HIMSS, the MEDTECH Act would allow the FDA to continue regulating EHR software that serves as an accessory to medical devices of medium or high risk, but would exclude EHR software considered lower risk from regulation in five specific areas:

• Software intended for administrative or operational support of a healthcare facility
• Products unrelated to clinical treatment of a disease or disorder,
• EHRs that “functionally represent a medical chart, including patient history records, but excluding diagnostic image data,” as long as the EHR system is “validated prior to marketing”,
• Software intended to format, organize or otherwise present clinical laboratory test report data prior to analysis;
• Software for analyzing and supporting the display or printing of patient or other medical information for supporting or providing prevention, diagnostic or treatment recommendations to clinicians.

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is regulatory legislation that that provides the FDA with the authority to:

• Collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics,
• Promote innovation to speed patient access to safe and effective products,
• Increase stakeholder involvement in FDA processes;
• Enhance the safety of the drug supply chain.

FDASIA included the Medical Device User Fee Amendments of 2012, or MDUFA III.
The intent of MDUFA III was to encourage greater collaboration and efficiency of regulatory processes between the medical device industry and the FDA to reduce the time it takes to bring safe and effective medical devices to the U.S. market. EHRs were not clearly distinguished and may have led to over-regulation of medical software at the “expense of continued innovation.”
MEDTECH Act is a response to that.

According to Massachusetts-based BCC Research firm, the global telemedicine market is expected to grow from $9.8 billion in 2010 to $27.3 billion in 2016, a compound annual growth rate of 18.6 percent over the next five years. Likewise, the telehospital market sector was worth $8.1 billion in 2011 and is expected to grow to $17.6 billion in 2016, demonstrating a 16.8 percent increase between 2011 and 2016.

The telehome segment is growing faster than the telehospital segment, however. This market segment was valued at $3.5 billion in 2011, and this revenue is expected to grow at a rate of 22.5 percent, reaching $9.7 billion in 2016. This growth is creating countless opportunities for all of healthcare, those in health IT, and those invested in developing new technologies to support the movement. In a nutshell, telemedicine helps physicians provide care using advanced, compact, and affordable technology, and reach countless new patients.

Given that, telehealth is known to improve efficiencies, reduce re-hospitalizations, and save money for the healthcare system. It’s doing more than that, though, as it’s helping patients, especially those with chronic conditions who require regular monitoring, consultation and education. Advanced TeleHealth Solutions, a provider of telehealth and telemedicine monitoring services, recently shared some research from the University of Michigan and the University of Kentucky. Apparently, the researchers there decided to review and analyze existing scientific evidence related to the impact of telemedicine on three issues affecting patient care — access, quality and cost — with a focus on chronic disease management, specifically for patients with congestive heart failure, cardiopulmonary disease (COPD) and those who’ve had a stroke.

For the research, researchers reviewed every available telehealth-related research paper published between 2000 and 2014 that focused on chronic disease management. Publications were chosen based on studies’ research design and the size of the sample group. Each study had to have at least 150 study subjects. They studied 177 references in total, and the findings led to the conclusion that over a broad range of patient types, level and intensity of patient participation and provider types, telehealth increases the quality of care for patients and reduces unnecessary service and cost. According to the study’s conclusion, “There is an ever-growing and complex body of empirical evidence that attests to the potential of telemedicine for addressing problems of access to care, quality of care and healthcare costs in the management of the three chronic diseases chosen for this review.”

According to the summation offered by Advanced TeleHealth Solutions, meaningful use of telehealth leads to significant reductions in hospitalization and emergency care visits, and aids in preventing or limiting illness severity and episodes, resulting in improved care outcomes. More and more, telehealth is proving to be a practice that rather than adding to inefficient services, it replaces inefficiencies with cost-effective solutions.

This finding is not a single event, either. According to the American Telemedicine Association, telemedicine has proven to save time, money and lives, and has done so for more than 50 years. With rising health expenses, an aging population and the increasing number of chronic diseases reported, the healthcare industry must continue to change how it operates and seek new solutions that ultimately lower or streamline costs while improving care for patients.

Telehealth seems to be accomplishing this goal.

The radiology sector of healthcare, for example, uses telehealth services copiously with more than 5 million patients having a diagnostic test read by an off-site specialist. Medical Economics reports that 1 million patients have pace makers monitored remotely, and about 400,000 patients receive mental health services via telemedicine.

The expansion of the use of telemedicine is obviously affected by the growth in mobile and even wearable technology, which increases individuals’ ability to reach beyond their geographic and physical location to receive care. However it is becoming more than a rural technology tool, and is helping create a sustainable platform of technology used for preventive care for millions of patients affected by a variety of ailments.

Citing a recent HIMSS survey, MobiHealthNews reports that 46 percent of healthcare providers use multiple telemedicine technologies with the most popular technology being two-way video messaging. HIMSS had 400 responses to its survey, and the results show that telemedicine continues to be adopted as a way to fill a need with limited resources throughout the healthcare systems.

The survey results are interesting:

• 60 percent of respondents use two-way video
• 55 percent use image sharing technology
• About 25 percent use remote patient monitoring
• Less than 20 percent use smartphones for telemedicine
• Only 23 percent of two-way video users integrate it with their EHR
• 88 percent of medication management users and 76 percent of patient portal users integrate those features.
• 33 percent said their interest in telehealth was part of a larger patient engagement initiative

Patient involvement and engagement is becoming the focus of telehealth’s growth, and creating the ability of physicians to directly engage their patients. As the population becomes more mobile, and technology allows them to better connect to their caregivers, patients will continue to seek ways to engage their providers, and telehealth is likely to fill that need.

According to the American Telemedicine Association, telehealth use shows decreases in hospital re-admissions and mortality rates, and increases patient engagement. As more buy in occurs, patients are likely to further engage – as is the hope – and care outcomes are likely going to continue improving.