1) Electronic health information exchange (HIE) allows doctors, nurses, pharmacists, other health care providers and patients to access and share secure patient medical information electronically—improving the speed, quality, safety and cost effectiveness of coordinated patient care.
2) Massachusetts is at the forefront of health information innovation, but lags in health information exchange due to inconsistent application of Federal law. Federal law allows release of information when needed for treatment, payment, and health care operations. For 43 states, this means an opt-out system for consent for all HIEs. For seven (7) states, including Massachusetts, this means an opt-in system is required, except for the Mass HIway.
3) The consent process for opting-out patients requires that all patients are informed about their records being available to other clinicians in the HIE along with where they can find more information about the risks and benefits. This can be in the Health Insurance Portability and Accountability Act (HIPAA) privacy notice. If the patient wants to participate, nothing further is required. If a patient does not want to participate (applying to very few patients) they need to properly identify themselves and are opted out centrally.
4) The consent process for opting-in patients requires that someone who can reliably identify the patient hands the patient a consent form and asks the patient to sign the form. Then the form must be sent from the reliable source to the HIE. The HIE must scan the form into the HIE to store it, and change the specific patient record from the default position of “opt-out” to the new position of “opt-in.” At least 97% of patients presented with the option of consenting to participate do so.
5) With 101 CMR 20.07, only the Mass HIway, and not the private HIEs, could move to an opt-out process to promote quality, sustainability and cost-effectiveness. While other HIEs in Massachusetts would similarly benefit from opt-out, the regulations state that this change applies only to the Mass HIway. This has been interpreted to mean that all other Massachusetts regional HIEs are opt-in.
6) Both options give patients the same choice, but opt-out promotes better healthcare. The opt-out process promotes sustainable and efficient care coordination. The opt-in consent process impedes the cost-effective and collaborative care that effective and secure information sharing promotes. As an example, 22,000 patients in the Lower Merrimack Valley have joined Wellport Health Information exchange and their complete clinical records are available to all their clinicians. Wellport has records on nearly 415,000 other patients. If Massachusetts were an opt-out state, many of these other patients would benefit from a comparable level of coordinated care.
7) The opt-in consent process subjects new and existing HIEs to substantial business risk. Physicians do not want to subscribe unless there is value to the HIE. Patients do not want to participate unless their clinicians are participating. The opt-in process means that no patients are participating when the HIE starts, and therefore few physicians will participate. Changing to an opt-out process will make it easier to start other regional HIEs and make expansion easier.
8) Opt-out consent frees clinical and administrative professionals in the HIE, the physician office, and the hospital to improve the coordination of patient care. The opt-out process requires much less of an investment in administrative support, promotes the delivery of improved services, and improves the health of the community.
9) Consistency in opt-out consent promotes patient and caregiver engagement without the risk of conflicts arising from conflicting processes. Opt-out consent simplifies the patient/caregiver relationship because it is consistent with the opt-out process for the Mass HIway.
10) The Massachusetts Medical Society’s policy is that the Massachusetts Medical Society will proactively work with appropriate stakeholders to change the Massachusetts consent process for sharing health information to a simple opt-out process for patients who do not wish to share their health or medical information with other providers caring for them.
11) The solution is to make regional exchange consent processes consistent with those of the Mass HIway. The following legislative language will accomplish that result:
An Act Promoting Health Information Exchanges
SECTION 1. Chapter 118I of the General Laws, as appearing in the 2014 Official Edition, is hereby amended by inserting after section 16 the following section:—
Section 17. The patient consent processes applicable to the statewide health information exchange, otherwise known as Mass HIway, as per Section 11 of this Chapter and applicable regulations, shall be deemed sufficient and proper patient consent for all health information exchanges in the Commonwealth[, regardless of their connection to or relationship with the state health information exchange.]
1) Require all health information service providers (HISPs) attached to the HIway to follow HIway consent processes.
2) A state official or agency unequivocally states that Massachusetts HIEs may use a consent process that allows regional HIEs to use the same consent process as the Mass HIway – or that Massachusetts HIEs may use a consent process that allows patients to opt-out rather than opt-in.
3) A lawyer or officer representing a respected Massachusetts statewide organization states unequivocally that Massachusetts law allows regional HIEs to use the same consent process as the Mass HIway – or that Massachusetts HIEs may use a consent process that allows patients to opt-out rather than opt-in.