1. Tapping Into the Mobile Health Opportunity

    “’If you don’t have mobility in your [healthcare] strategy, then you don’t have a strategy,’ said Allina Health System’s Susan Heichert at a 2012 national health information conference.”

    Two recent updates from law firm Duane Morris provide a solid overview of the opportunities and legal considerations of “mHealth,” as mobile health is increasingly known. 

    For your reference, key takeaways:

    What is mHealth? 

    “Various definitions of mHealth exist in the marketplace as the field defines itself, but they all share certain identifying characteristics. Generally, mobile health is healthcare delivered through mobile communication technology, such as applications on an iPhone or web-based software accessed through a mobile device… 

    Here is a [simple] definition: mHealth is defined by three fundamental characteristics: 1) a device or software that is 2) health oriented and 3) has mobile use.”

    How big is the opportunity?

    “As funds for traditional healthcare—doctors’ visits, hospital stays, long-term nursing home residencies—dwindle, some estimates indicate mobile device revenue will reach $1.9 billion globally by 2014.” 

    Who are the players?

    “They include device makers, software and app developers, investors, providers, payors and insurance companies, not to forget the government and consumers.” 

    What are some key legal issues?

    Intellectual property: “Once a concept has been sufficiently developed to promote and disclose, it may die on the vine if intellectual property legal issues have not been appropriately addressed, such as patents, copyrights, trademarks and contracts.”

    Federal and state regulation: “Healthcare is a highly regulated industry, and becoming familiar with specific agency regulations and guidance, along with the direction of enforcement, can be daunting and may require legal support.”

    Insurance coverage: “With any new area of commerce, especially with medical devices where injury could result, it may be challenging to find an insurer that understands and will insure the risk. Specialty insurance brokers may be required to find such coverage. In some cases, the risks may not be insurable. Insurance issues usually arise while an agreement is being negotiated, but they should be a significant consideration of every business plan.”

    Privacy considerations: “A stakeholder should pay special attention to what, if any, patient information, protected under any federal and/or state laws, requires special documentation before that information can be shared. Under HIPAA, some vendors receiving protected health information will have to execute business associate agreements that must conform to the requirements of the law.”

    Fraud and abuse: “Many complex billing issues give rise to potential fraud and abuse issues. For example, physicians have been accused of fraud for billing for services when they are not physically present at the time the service is being rendered.”

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    Read the updates: 

    mHealth: Technology’s Healthcare Reform (Duane Morris LLP) 

    mHealth Stakeholders: Bullet List of Legal Considerations (Duane Morris LLP) 

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    Related Reading:

    FDA Draft Guidance for Industry on Mobile Medical Applications Released (International Lawyers Network) 

    FDA Issues Draft Guidance on Mobile Medical Apps Does the App Present a Risk to Patients if it Does Not Function as Intended? (King & Spalding) 

    Draft Guidance Clarifies How FDA Plans To Regulate Certain Software “Apps” (Ropes & Gray LLP) 

    New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions (Morgan Lewis) 

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