Health and Fitness Panel : Media & Entertainment Technology

October 16, 2012, CEA Industry Counsel, San Francisco?A panel reviewed the issues associated with health and fitness CE products. Rob McCray from Wireless-Life Sciences Alliance was the moderator. Panel members included Igor Gershfang from Walgreen, David Inns from Great Call, Clint McClellen from Qualcomm, and Brad Thomsen from Epstein, Becker & Green Law firm.

This is a field where all bodies of knowledge--science, math, engineering, health, etc.--have to come together. Living near the boundaries are the insurance companies, doctors, and regulators.
Inns noted that everything is getting connected. It now makes sense to bundle services with a Jitterbug phone, such as 5 star emergency response and other safety services with the basic phone services. Other apps are available on tablets fueling an increase in adoption of hand-held services. Still, there are many barriers. One is money. The insurance carriers need to be included to make the market scale. Second, the distribution channels are not well established. There are no simple, clear entry points, and no tools to help the consumer understand their results. And finally, the market doesn't really know the consumer.

Customer focus on the elderly?
Gershfang commented that the health and services are moving to the care providers, whose goals are to reduce costs, achieve better outcomes, and provide remote care. The driver is affordability, since the health care system is at or near saturation. The population of aged is increasing by over 10,000 people per day, with many signing up for Medicare. Innovation and advances in mobile technology are empowering consumers and opening up new markets for alternative healthcare delivery. One example is retail clinics in stores. These clinics offer diagnostics and wellness services, and provide a platform for other services. These clinics need a services layer, supplemented with appropriate hardware, advisors, etc. to be effective. Changing behaviors requires products that are easy to use and have good support.
McClellen added that wireless communications are a key part of the healthcare changes. The connected services all use the smart phone as a platform, or hub. Many of the services are on separate networks, and plug in to Android or iOS devices. Effective virtual hubs need standard interfaces to the apps, and have to supply context information along with the basic data. The phones need SDKs and building blocks to integrate with the sensors.
Thompson noted that sector knowledge is critical. Currently, the FDA is debating the issue of regulated versus unregulated devices and tools. Some of the issues relate to wellness versus disease. The law states that any device or accessory that is used to cure or mitigate a disease or other medical condition is under their jurisdiction for regulation. There are some defining terms and lists of diseases. A device that collects data and shares them with a physician is to be regulated. Most of the rules need clarification. For example, the accessory rule states that anything that attaches to a medical device is a medical device. So, an app that tracks blood glucose gets defined as a medical device.

Software and apps are medical devices subject to regulation. Companies under the regulations have to operate differently than those that are not regulated?
Thompson stated that most apps fall into a middle category of risk and are not actively regulated. The FDA is watching the market. There are intentional and unintentional regulations. Final guidance is expected by the end of the year. Currently, information delivery and communications are not regulated, but anything with a specific relationship with a disease will be classified as a medical device. Those that display diagnostics are medical devices.
McClellen commented that their hubs fall under FDA regulations. They are using PCI for its high security.
Inns noted that they will be filing for regulation. The HIPPA and other acts define privacy and security as important. The data privacy and security for consumers is a big issue.
Gershfang said that consumers are buying $30B in unproven supplements every year. Effort to define the consumer in the channels indicate about 6 million people a day, and all access to the medical system is over 10 million people a day.

McCray mentioned that health devices are still trying to find their places in distribution channels. One issue is that there are many categories of consumers: early adopters, wellness and fitness, worried well who will generate data and require analysis, pre-chronics who are trying to stay well, chronic, short-term monitor, aging in place, and the professional and family caregivers. The drivers are to gain adoption and engagement, which will need a service wrapper around the product. Prices will have to drop, and the devices need to provide seamless user experiences to affect consumer awareness.
Inns considered that it is difficult to get to a realistic solution.
Gershfang agreed that a complete solution is necessary.
McClellen observed that all the devices need to supply emotional and motivational feedback to keep people engaged. There are no baselines for the different levels of consumers, so the manufacturers need to make multiple device integration easier.

Elderly focus? Apps developers need domain-specific expertise, etc. How much is this like consumer electronics?
Inns stated that the industry needs to work on awareness, distribution models, marketing, etc.
Thompson commented that entrants to the sector coming from the CE sector need to understand that regulations matter. A survey of the app store showed that as much as 10 percent of the apps may be subject to FDA regulations, and are currently non-compliant. As many as one third of the health apps may be subject to the FDA regulations. Many CE makers don't realize that they are getting into the regulated medical device realm.
McClellen offered that some of the devices will transform healthcare. For example, their ECG meter gets its data backed up with software, analytics, and expert systems, so the data can be sent to cardiologists. If the data indicate a problem, the system will send a message to the user to check in to a medical facility.

FDA quality processes are trying to address the issues, reduce costs, and want to help?
Inns stated that companies have to work with the FDA, and not try to get around them.
Greshfarg suggested that class 1 devices ?the lowest level risk type?only have to have QA procedures and ISO-level compliance.

Interfaces, and make or not make devices?
Thompson concluded that it is hard to determine and make money. The FDA is not punishing companies, but this may change with the new guidelines. It's likely that they will move towards higher levels of compliance.

One third of healthcare costs are wasted, about $700 B per year. How do we get better quality and consistency?
Thompson noted that the regulated activities are only part of the issue. Manufacturers have to decide if they are going to be certified or controlled in other ways.
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Posted by Tets on Tuesday, November 6, 2012 at 5:47 pm?
Filed under Featured Content, New Technology, Tradeshows ? Tagged with CEA, consumer, data, devices, Event, health, Medical, regulations, services

Source: http://mandetech.com/2012/11/06/health-and-fitness-panel/

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