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Mobile health technologies promise improved healthcare at lower cost. With the US, EU and Japan facing difficult economic conditions, 2013 should be the year of broad mHealth adoption. However, the mHealth agenda in the US is dominated by a few key federal government agencies, including the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC) and US Patent and Trademark Office (USPTO). Reviewing the current priorities at each agency can provide a roadmap for the 2013 mHealth sector.
Both Congress and the Obama administration would like to lower Healthcare expenditures. At 17.9% of GDP (nearly $8,000 per American), by 2016 the US will spend $3.5 trillion annually on healthcare, more than the entire German economy. mHealth is considered a means to lower healthcare costs, particularly for chronic diseases. In four years, PWC predicts mHealth global revenue to reach $23 billion. The regulatory and industry inertia has slowed implementation in the US. According to Susan Dentzer, Editor in Chief of the academic journal Health Affairs, “clearly the US is the developing country when it comes to mHealth”.
FDA: In the United States, the Food and Drug Administration (FDA) has responsibility for ensuring that medical devices, and now medical applications, are safe and beneficial. Representative Mike Honda (D-CA) has proposed an Office of Mobile Health within the FDA, part of a larger bill called HIMTA (Healthcare Innovation and Marketplace Technologies Act). This new section would align and coordinate issues related to mobile health technology across the FDA, other agencies, working groups and government commissions. Currently, regulating mobile applications and devices is done by the FDA’s Center for Devices and Radiological Health (CDRH).
Unfortunately, they are not doing a very good job. A report by the New England Center for Investigative Reporting found that the app stores are "riddled with health apps that experts say do not work and in some cases could even endanger people". The size of the mobile health applications market is enormous. Pew Research notes that 19% of Smartphone owners have health applications. Research2Guidance estimates 247 million mobile phone users will download health apps this year, nearly double the number from last year. Unfortunately, app stores are awash in bogus medical claims. Expect regulations next year clarifying which categories of health apps require agency approval before being marketed.
Another issue the FDA has promised to address next year is standards for regulating remote or internet-based medical screening and diagnostic tools. Technologies to self-screen for a particular disease or condition can help consumers self-diagnose, eliminating unnecessary trips to the doctor’s office.
FCC: Julius Genachowski, FCC Chairman, promised in September to hire a permanent FCC Health Care Director in 2013. This executive will be the principal point of contact with external groups for all health-related issues.
Simplifying the complicated rules for allocating wireless spectrum for mHealth technologies may be the FCC’s biggest health-related priority. As part of its licensing rules approved in 2010, the FCC instituted a program that establishes wireless test beds for medical purposes to ensure the proper performance of mobile health devices. The explosive growth in connected devices (telecom equipment vendor Ericsson predicts 50 billion connected devices by 2020) will require a greater allocation for mHealth technologies.
The FCC’s International Bureau has its own objective for 2013- encouraging their international counterparts to allocate spectrum for Medical Body Area Networks (MBANs). These are low-power wideband networks consisting of multiple body-worn sensors that transmit patient data to a device. International spectrum harmonization would enable safe, cross-border patient travel and better economies of scale for device makers.
CMS- Centers for Medicare and Medicaid Services: The organization is responsible for encouraging adoption of Electronic Health Records (EHR’s) through incentive payments to doctors, hospitals and health care providers. Despite a slap-down from the Office of the Inspector General last month, the program has been well-received by the medical community. Through September, 2012, CMS paid out $4 billion in incentives to 82,000 professionals and more than 1,400 hospitals. The key change in 2013 is the interpretation of “meaningful use” from the perspective of compliance and security.
Compliance standards will become much more stringent in 2015. Providers that cannot demonstrate meaningful use of electronic health record systems will be penalized through reduced Medicare and Medicaid payments for services rendered.
From a security perspective, the federal baselinefor health information privacy and security protection (HIPAA- Health Insurance Portability and Accountability Act), will be updated to reflect the mobile era. New guidelines will specifically tie financial incentives with encryption of data stored in EHR’s on mobile devices or applications or any personal health information on end-user devices.
FTC: The role of the Federal Trade Commission is to prevent fraudulent, deceptive, and unfair business practices. This would seem perfect for fighting the deluge of fraudulent mobile healthcare apps (more than 20%). However, under the guidelines of the Food and Drug Administration and Safety Act, signed into law in July, any application that transforms a mobile handset into a medical device is under FDA jurisdiction, not the FTC.
Despite lacking direct jurisdiction, earlier this year the FTC fined two app developers that falsely advertised the efficacy of their applications to treat acne. The settlements with AcneApp and Acne Pwner ban the developers and sent a message to other would-be hucksters. Since then, the FTC has not announced an expanded role in mobile healthcare oversight.
Filling the void are private sector groups. Haptique, the healthcare-focused appstore and mobile app prescription technology vendor, published a draft document in July for the mobile health app certification process. These guidelines help measure an app’s operational integrity, security, privacy policies and content.
USPTO: The US Patent and Trademark Office, which has a backlog of more than 1.4 million applications, has been unable to match the fast pace of the mHealth market. Their task was simplified somewhat when the America Invents Act (AIA) was signed into law by President Obama with the goal of streamlining the patent process, improving access for small inventors and better protecting businesses from patent trolls. Based on the requirements set by the AIA, the USPTO has been introducing many changes to the examination process, adjusting fees, hiring more patent examiners and rolling out satellite offices in Dallas, Denver, Detroit and Silicon Valley.
Even with these changes, patenting continues to be an expensive process. Kenichi Hartman, US Patent Agent at IP Firm Yagod Morris, recommends three defensive, and inexpensive, steps that are within the reach of most independent app developers and start-ups.
1) Draft the description of the invention yourself and file as a US provisional application. The accords the applicant the priority date for the invention worldwide and one year to decide whether or not to continue.
2) File this document electronically with the USPTO, without the involvement of a licensed US patent agent or attorney. The involvement of a licensed US patent agent or attorney for initial filing is not a requirement.
3) Think beyond copycats. Avoid copy-cats by registering the copyright for the app with the US Copyright Office.
Israeli mobile health companies are focused on areas like home monitoring, chronic disease management, virtual health records, medication compliance, clinical applications, hospital administration, consumer and physician tools, laboratory management, etc. Some interesting companies include the following: Card Guard, Bircon, Hypno Core, Global Medical Network / Life on Key, Irody, eon Medical, Aerotel, dbMotion, Cliniworks, Logitag, SporTracker, Wellness Layers, SHL Telemedicine, Itamar Medical, Commwell, Med CPU, MediScale, Treato, Kyma Medical Technologies, EarlySense, Haldor, Healarium, Sensible Medical Innovations, HomeFree, American Well, Medic4all, BioData / Lab Guru, eWaveMD, BioLert Ltd and BioGaming, Elitar, Hyginex, Shina Systems, Vaica Medical, Medpal Health Solutions
There is no doubt that mobile devices are transforming healthcare. Less certain is whether key government agencies, including the FDA, FCC, FDA and PTO will adopt regulations next year to accelerate this transformation.