Two recent news stories caught my eye. One is about a pharmaceutical package produced by Proteus Biomedical, a U.S. company, that will be on the market in the UK this fall. A patient’s medication will be shrink wrapped for each dose. As an example, the first package in the morning may include four pills for medication and an additional pill. When the patient opens the package and swallows all five pills the fifth one is activated by liquid in the stomach and transmits a signal to a patch on the patient’s body. The patch tracks when the drugs were taken, heart rate and body temperature and whether the patient is sleeping well or taking enough exercise. The patch then forwards a signal to a Web based device such as a smart phone which sends a message that the patient has taken their medication and the other data.
The other news story is a GPS based device in the heel of the shoe for Alzheimer’s patients. A care giver defines a “safe area” on something like a Google map. If the patient wanders outside the defined area, the device sends an alert. It then continues to send a signal so that he can be found or a caregiver will be notified that he has returned to the safe area.
One works when what is expected happens: mom takes her pills. No news is bad news. The other happens when the unexpected happens: dad wanders away from home. Any news is bad news.
Today we have no way of knowing whether mom has taken her pills or dad has wondered or where he has gone. In the near future when we can know, who needs to do what and when?
Who?
There are two primary options in response to who? Either paid and trained professionals or unpaid family, friends and neighbors. This job is a bit like that of a person in a 911 center who has either almost nothing to do or a potential crisis that must be dealt with now. It is not a supplemental role for today’s medical professionals. It may require nothing other than a series of phone calls or it may require actions and directions to deal with a serious situation. For the moment, let’s call that role: tracker.
Does What and When?
As part of the treatment plan for a patient who has a critical need to take one or more pills at or very near specified times throughout the day a physician, nurse or perhaps a new kind of specialist will develop a tracking plan. If mom will be tracked by a professional (paid) tracker, the plan can be an annotated outline. If her tracker will be a relative, friend or other tracker with limited medical experience, a more detailed plan may be required.
As an example, if mom is supposed to take a pill every four hours how critical is it if contact cannot be made after five, six or even seven hours? When should paramedics be called? If contact is made after seven hours are there any symptoms of problems that should be assessed? Should she take one pill or two? This type of information needs to be readily available in the tracking plan. In practice, there will almost certainly be situations that cannot be fully anticipated and the tracker will have to have appropriate skills and experience.
The plan may involve the use of a telephone and person-to-person calls; or it may make use of automated equipment to make calls and respond to voice prompts. The following simplified diagram illustrates how an automated system might work; each box could have several additional options and “action based on circumstances” can get very complex.
Medical Device Tracker Cycle
Standard of Care
If we have no way of knowing something there is no obligation to know it. On the other hand, if we can know whether or not mom has taken her pills there may be a legal obligation to know it and take appropriate action. The availability of information about a patient using a device that reports potentially dangerous circumstances will probably create a new standard of care.
Litigation and Insurance
We are a litigious society. If a tracker is unable to initiate or complete a defined tracking process what liability, if any, is created? Do trackers need insurance? What form will that insurance take for paid and unpaid trackers?
Will insurance cover the cost for paid tracking? If timely medication is important for patient recovery and safety it seems reasonable to cover the costs with insurance.
EHR Excerpts
There may be information that is critical to the tracker’s assessment of the circumstances and the best courses of action, e.g., if mom does not take her pills within four hours there is a possibility of [fill in the blank] and the following actions should be taken. This information needs to be kept current. A link between the tracker and relevant portions of mom’s EHR will assure that current data is always available to the tracker or others that may be called on to assist, e.g., paramedics.
The system tracking capabilities, shown in green on the diagram, could be built into an EHR with secure interfaces to trackers. This would provide protection for the transmission of information to the doctor to comply with HIPAA as described in mHealth Challenges Around Privacy and HIPAA.
Equally important, the additional data provided from the sensor would be useful for the physician in assessing the effectiveness of the medication and spotting any side effects. This additional data could be an important part of the patient’s record.
The increasing use of devices to track patient conditions and actions will create increasing amounts of data that must be tracked in near-real time. This creates a need for new support systems and people to assure that the potential benefits are realized.
Links:
First article – http://www.dailymail.co.uk/health/article-2087275/New-smart-pill-tells-patients-dose-due.html
Second article – http://www.gpsshoe.com/
Privacy blog http://www.practicefusion.com/ehrbloggers/2012/02/mhealth-challenges-around-privacy-and-hipaa.html?utm_source=rss&utm_medium=rss&utm_campaign=mhealth-challenges-around-privacy-and-hipaa
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