SPOTLIGHT
Five exceptions involve not fulfilling requests to access , exchange , or use of electronic health information : preventing harm exceptions , privacy exceptions , security exceptions , infeasibility exceptions , and health IT performance exceptions . Three exceptions involve procedures for fulfilling requests to access , exchange , and use of electronic health information : content and manner exceptions , fees exceptions , and licensing exceptions . ( See SIDEBAR 1 for details .)
“ Congress was attempting to better engage patients in their health care and do so in ways that were beneficial to them ,” said Robert James Horne , president of health care lobbying firm Forest Hill Consulting , and former staff on the health subcommittee of the House Committee on Energy and Commerce . “ While progress has been made , it remains to be seen if the health care system can achieve the goal that Congress was legislating on .”
( The Centers for Medicare and Medicaid Services introduced a counterpart to the Cures Act ’ s information blocking requirements with its Interoperability and Patient Access final rule . Read more about this program in SIDEBAR 2 .)
Real-World Benefits , Real-World Harms
“ Patients absolutely have the right to have access to their medical records and their chart , which allows them to educate themselves about their diagnosis and treatment options . I encourage it ,” said Jamile M . Shammo , MD , professor of medicine and pathology at Rush University Medical Center and American Society of Hematology Councillor . “ In my experience , the more a patient knows about their disease and the more they are able to partner with their physicians , the better the outcomes .”
Another potential benefit of unfettered access to electronic health information is facilitating second opinions , added Dr . Stevens .
“ Anybody who has gotten medical records through the typical pathways knows how challenging it can be ,” Dr . Stevens said . “ When people are seeking second opinions , [ interoperability ] will make it a million times easier to get the data that clinicians need to render a useful commentary .”
The rule ’ s interoperability requirements also will allow for a better exchange of information between institutions , according to Jean M . Connors , MD , associate professor of medicine at Harvard Medical School and medical director of the Anticoagulation Management Service at Brigham and Women ’ s Hospital and Dana-Farber Cancer Institute .
“ A patient may not completely understand their diagnosis , why they are taking certain medications , or what those medications even are ,” Dr . Connors said . “ These newer requirements grant other providers access to records that tell them what happened and when it happened . That can be lifesaving information .”
“ The provision was designed to create interoperability in the exchange of information , which is the bedrock of the entire health care system ,” Mr . Horne told ASH Clinical News . Take for example , Medicare , Mr . Horne said . “ People think of Medicare as one program , but it is actually nine , 10 , 15 segmented payment systems or programs . This approach to care diminishes opportunities to improve functional outcomes for patients .”
Interoperability creates new opportunities to coordinate care . “ Now , at any point a patient touches the health care system , there are more data available to help decide on current or future actions . The expectation of the legislation is that greater efficiency and a fuller picture of what is going on with a patient will improve outcomes ,” he explained .
The potential benefits of the information blocking rule are vast , but these benefits exist in parallel with concerns about its real-world implementation . Whether a physician ’ s “ open access ” to the electronic medical record is the best way to improve patient care is a matter of debate .
Colleen T . Morton , MBBCh , section chief of classical hematology at Vanderbilt University Medical Center , said that Vanderbilt previously had a 14-day delay in the release of sensitive test results that might have significant implications for the patient ’ s health .
“ With the policy , we wanted to give the clinician time to contact the patients and discuss the results ,” Dr . Morton said . “ That is going away . Now patients may see their results before we do .”
Putting results into context is incredibly important to avoid unnecessary anxiety or confusion , she said .
For example , if patients see the word “ leukemia ” on bone marrow biopsy results they might panic . “ They likely don ’ t understand that there are different types of leukemia ,” Dr . Morton explained . “ Getting a diagnosis of chronic
SIDEBAR 1
Exceptions to Prove the Rule
HHS ’ Office of the National Coordinator for Health Information Technology has finalized eight exceptions through which practices can delay access , exchange , or use of electronic health information ( EHI ). All of these exceptions have key conditions that need to be met to qualify .
1 . Preventing harm exception : It will not be information blocking for an actor to engage in practices that are reasonable and necessary to prevent harm to a patient or another person .
2 . Privacy exception : It will not be information blocking if an actor does not fulfill a request to access , exchange , or use EHI in order to protect an individual ’ s privacy .
3 . Security exception : It will not be information blocking for an actor to interfere with the access , exchange , or use of EHI in order to protect the security of EHI .
4 . Infeasibility exception : It will not be information blocking if an actor does not fulfill a request to access , exchange , or use EHI due to the infeasibility of the request .
5 . Health IT performance exception : It will not be information blocking for an actor to take reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT ’ s performance for the benefit of the overall performance of the health IT .
6 . Content and manner exception : It will not be information blocking for an actor to limit the content of its response to a request to access , exchange , or use EHI or the manner in which it fulfills a request to access , exchange , or use EHI .
7 . Fees exception : It will not be information blocking for an actor to charge fees , including fees that result in a reasonable profit margin , for accessing , exchanging , or using EHI .
8 . Licensing exception : It will not be information blocking for an actor to license interoperability elements for EHI to be accessed , exchanged , or used .
Source : Office of the National Coordinator for Health Information Technology , “ Cures Act Final Rule : Information Blocking Exceptions .”
SIDEBAR 2
CMS Counterpart
A counterpart to the Interoperability , Information Blocking and the ONC Health IT Certification Program Final Rule is the Centers for Medicare and Medicaid Services ’ ( CMS ’) Interoperability and Patient Access final rule . According to CMS , this rule places new requirements on Medicaid and Children ’ s Health Insurance Program ( CHIP ) managed care plans , state Medicaid and CHIP fee-forservice programs , and Qualified Health Plans ( QHP ) issuers on the Federally Facilitated Exchanges ( FFEs ) to improve the electronic exchange of health care data , and streamline processes related to prior authorization . This rule , which had a compliance date of January 1 , 2021 , focuses on health-care payers instead of providers .
lymphocytic leukemia at age 80 may not significantly impact your life and health – it is a common diagnosis and we often just monitor it – whereas a diagnosis of acute myeloid leukemia is a medical emergency .”
In addition , a single test might not paint the entire picture . Dr . Morton said that bone marrow biopsies are often first examined under a microscope and given a general description and differential diagnosis . Specimens are then sent for genetic testing . Those results may change a diagnosis .
“ Genetic testing results come back a week or two later and are not included in the initial report ,” Dr . Morton said . “ That means a diagnosis may change from initial release to final report .”
In other situations , a patient may receive complete blood count results and panic about an abnormality .
“ We have had people send us a barrage of messages asking what their slightly abnormal test results mean when , in the context of that patient ’ s history , the finding has no clinical significance . It still makes the patient anxious , leading to multiple patient phone calls or patient portal messages ,” Dr . Connors said . “ This often occurs after a patient has left the clinic , so we are faced with making unscheduled calls and answering emails . It is extra work
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