OBJECTIVES: Companion devices enable Mobile Health (mHealth) via remote monitoring of patients’ biometrics. By 2020, the global mHealth market is estimated to reach $6.28 billion.  While mHealth is expected to revolutionize delivery of patient care, especially for chronic diseases such as diabetes or asthma, it has not realized its full potential. To that end, the objectives of this study were to: 1)      Characterize benefits that companion devices may deliver to key stakeholders, including patients, Health Care Professionals (HCPs), payers, and drug manufacturers; 2)      Determine how HCPs currently utilize companion devices and key unmet needs; 3)      Identify perceived roadblocks by payers in coverage & reimbursement of companion devices. METHODS: Health Technology Assessments (HTAs) and guidelines published between 2010 and 2014, and publications archived in MEDLINE and PubMed were analyzed to assess potential benefits, challenges, and historical valuation of companion devices.  Additionally, approved companion devices were evaluated to assess their coverage and reimbursement and associated evidence requirements in the US and 5 major EU markets. RESULTS: Companion devices can potentially deliver benefits across the continuum of care that may be categorized into three areas: patient management (adherence and compliance), disease management (clinic visits and trend alerts), drug management (dosage and clinical events). Current barriers to adoption appear to be primarily cost of technology, potentially increased liability exposure, compliance with patient confidentiality, challenge in demonstrating positive budget impact, and importantly, lack of optimal reimbursement (separate vs bundled payment). CONCLUSIONS: While relatively nascent, companion devices are expected to play a role along the full continuum of patient care: from prevention, diagnosis, treatment, to monitoring. As such, this study indicated that the integration of companion devices with care plans is potentially hinged around three key issues: a) patient education and awareness, b) physician engagement via streamlined clinical workflow, and c) demonstration of long-term economic benefits to payers.