mHealth + Telehealth World 2015

The FDA has been working to clarify the scope of its regulation over mobile health over the last few years. A September 2013 Guidance spelled out its oversight for some of the most common mobile medical apps; January 2015 Draft Guidances addressed oversight of apps for general wellness and ones that may be accessories to medical devices; and a February 2015 Final Guidance deregulated medical device data systems (including many mobile apps). Another guidance is expected to be issued soon providing clarity around apps that guide the appropriate use of drugs, many of which would be categorized as Clinical Decision Support software. In this session, gain an update as to what mobile health technology is regulated, what’s not, and what may still be under consideration to be regulated.

• Outline the eight types of apps developed by pharmaceutical companies for use in conjunction with one of their drugs
  • Identify the types of borderline products that FDA did not wish to regulate, or are so low risk they do not merit FDA oversight
• Delve into which of these groups of apps currently are, or may be, regulated
  • Understand which apps are regulated as a part of FDA’s drug labeling
• Examine the considerations around regulation of Clinical Decision Support for either patients or health professionals
• Analyze the impact of the September 2014 International Medical Device Regulators Forum document on Software as a Medical Device as it relates to the potential FDA regulation of medical device software
• Learn about the bills currently being considered by Congress that would clarify the rules for pharmaceutical companies looking to help doctors and patients make more appropriate use of drugs

Medication non-adherence accounts for approximately $300 Billion in avoidable health care costs. Improving medication adherence has many benefits – preventing adverse health outcomes, managing the progress of chronic disease, lowering costs, and improving star ratings – but it is not an easy task. In this case study, hear about a new approach being tested to improve medication adherence for heart attack survivors where researchers are evaluating a series of behavioral and economic motivational tools to improve medication adherence.

• Leverage new technology to monitor medication adherence, including a Bluetooth-enabled pill bottle that communicates wirelessly with the research servers
• Explore behavioral economics tools that include reminders sent via text message and email

Issues of licensing and credentialing prevent providers from delivering care to those outside of their practicing state, even though mHealth and Telehealth increases access to providers across the country and around the world. Additional regulatory activities are also arising that have an impact on the expansion of connected health programs.

• Understand the recent “Model Policy” adopted by the Federation of State Medical boards and how it impacts connected health programs
• Discuss the proposed solutions to licensing and credentialing issues and when the industry should expect a change
• Uncover the activities around defining the establishment of a doctor-patient relationship and the impact on prescribing

According to industry reports, an estimated half billion people across the globe will be using mobile health apps this year. Mobile health solutions have the potential to dramatically change the delivery of health care — tackling challenges such as disparate access to care, federal budgetary constraints, and care coordination — and encouraging patients to take a more active role in their health. However, the most cited concern relating to the widespread adoption of these technologies is the inherent privacy and security threats. In order for mHealth to become an integral part of the health care delivery system, patients need to have confidence that their personal health information will remain confidential and secure. Health care has been identified as the hot target for cyber threats and intrusions and regulatory agencies domestically and abroad have been far outpaced by the industry’s technological advancements.

• Understand the complex regulatory landscape facing mHealth in the areas of privacy and security, at both a national and international level
• Identify the threat landscape and the particular vulnerabilities and areas of concern associated with mHealth devices and applications
• Discover the proactive measures organizations can incorporate into their product development, marketing, distribution, and operations to minimize privacy and security risks and enhance regulatory compliance.
• Examine the policies, procedures, contract provisions, and insurance coverage that organizations can adopt in order to minimize their downside risk associated with mHealth privacy and security threats

As initial connected health programs are implemented and organizations start to see results, hospitals, health systems, and health plans then look to expand programs to other populations, specialties, and facilities.

• Understand current programs and future expansion of these programs
• Assess opportunities for the organization and prioritize these opportunities
• Explore strategies for adapting implementation plans to new programs

The Telehealth industry is going through unprecedented growth. What was once a fringe concept is now the most exciting advancement in health care. As changes in reimbursement and regulation drive interest and adoption, technology advancements are putting tools in the hands of clinicians, and rapidly expanding clinical applicability. The result is broad adoption across the health care ecosystem throughout the care continuum.

• Understand consumer Telehealth experience, technology and adoption drivers
• Learn about the recent arrival of Telehealth 2.0 technologies and their impact on care across the health care ecosystem
• Recognize technology requirements of patient-initiated and provider-directed Telehealth
• Review key industry developments driving exponential growth and adoption

When implementing or expanding a connected health program, organizations must assign governance and develop a system strategy in order to be successful. In this session, hear how one large organization has created an enterprise imaging strategy for managing clinical imaging content and the issues it has faced.

• Discuss the imaging challenges facing larger organizations and identify opportunities to optimize image acquisition, workflow, management, access, and storage
• Identify steps for establishing an enterprise governance structure that provides direction and oversight for a multi-facility, multi-department image management program
• Understand the benefits an enterprise imaging strategy can enable when tightly integrated to the EMR and which provides access to all types of clinical images regardless of type or point of acquisition

Many connected health programs began with a focus on primary care specialties, and now have expanded to specialty care. Even so, most of these programs have not yet incorporated connected health technology in procedure-based specialties. In this session, hear from an organization that has incorporated connected health into care centered around procedures.

• Explore how mHealth and Telehealth can be used to serve a patient both before and after surgery
• Discover how use of connected health with procedure-based care differs from its use with other specialties
• Uncover the impact on cost and convenience for these services

As organizations continue to implement and expand connected health programs, there are an increasing numbers of companies developing technologies to improve the efficiency and effectiveness of these programs.

• Assess the market offerings for connected health
• Discuss best practices for choosing which technology meets an organization’s specific needs