The Information Blocking Rules are complex, but many hospitals are just looking for a few, bottom-line answers about effective dates, potential penalties, and whether patients must really get access to all lab and imaging results immediately – even if a physician would rather explain potentially devastating results first.

“Information Blocking” means a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of Electronic Health Information (EHI) when a healthcare provider knows that the practice is unreasonable and is likely to interfere with access, exchange, or use of the EHI.  (Reference 45 C.F.R. §171.103)

The rule applies to “Actors” which are not only healthcare providers, but also developers of certified health information technology, health information exchanges, and health information networks who are all prohibited from interfering with access to EHI unless one of the exceptions apply.   (Reference 45 C.F.R. §171.101, 102)

In a word, yes.  The Office of the National Coordinator for Health Information Technology (ONC) addressed this issue in its March 2021 FAQs in a response that explained:  “It would likely be considered an interference for purposes of information blocking if the healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or an order to personally inform the patient of the results before a patient can electronically access such results. (see also 85 FR 25842 specifying that such a practice does not qualify for the ‘Preventing Harm’ Exception).”   

While there is a “Preventing Harm” Exception, it is limited to physical harm, so it would not generally include emotional or mental anguish.  Even though a patient may suffer severe distress upon reviewing bad results before having a discussion with his/her physician, this type of harm does not qualify for the exception.  (Reference 45 C.F.R. §171.201)

An organizational policy that provided a blanket restriction would be problematic.  The “Preventing Harm” Exception is on a case-by-case basis, so a hospital should not set up a policy that, for a certain type of situation, lab results would be withheld, regardless of how emotionally devastating those results might be.  The ONC FAQs explain: “Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.”

The physicians should address this on a case-by-case basis, and one approach could be:  

• The physician could educate the individual patient receiving the test on the Information Blocking rules and explain that the lab/imaging report must be available to the patient immediately on the portal when the hospital receives it, at the same time the physician will receive it.  

• The physician can explain that the particular lab or radiology result can be confusing and that if the patient would prefer to meet with the doctor and discuss the results prior to seeing them that it is possible to withhold that and restrict it from the record until the patient has had a chance to talk with the physician about it.  

• If the patient agrees, the physician would complete an individualized, patient-specific exception form dated and signed by both the patient and the physician, to demonstrate compliance with the exception and avoid allegations of information blocking. 

Another instance where the exception form could prove useful is when a patient does not want information appearing on their portal, for example where a patient’s spouse has access to their portal, and the patient wants to maintain strict confidentiality of test results (such as for STDs).  

ONC and the Center for Medicaid and Medicare Services (CMS) released a proposed rule on Oct. 30, 2023 to establish “appropriate disincentives” for healthcare providers determined by Office of Inspector General (OIG) to have committed information blocking.  This proposed rule by ONC and CMS only contained proposed disincentives for healthcare providers that participate in the Medicare Promoting Interoperability or Medicare Shared Savings Program, or that serve a limited number of Medicare beneficiaries.  Under the proposed rule, ONC and CMS propose to use the existing Medicare Promoting Interoperability Program for the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and critical access hospitals (CAH).  Under the proposed rule, an eligible hospital or CAH would not be a meaningful EHR user in an EHR reporting period if OIG refers its determination that the eligible hospital or CAH committed information blocking during the calendar year of the reporting period.  A hospital would be unable to earn the three quarters of the annual market basket increase, and the CAH would have its payment reduced to 100% of reasonable costs, down from 10%. 

Yes.  Providers frequently have difficulty in getting information from Health Information Technology (HIT) vendors, particularly when changing or terminating IT vendors.  The Information Blocking rules also apply to health IT developers of certified HIT, health information exchanges, and health information networks.  Those entities violate the rule if they know or should know that their practice is likely to interfere with access, exchange, or use of electronic health information.  These rules, combined with Federal Trade Commission enforcement against anti-competitive conduct, may even be of assistance to hospitals faced with unreasonable charges from vendors to extract and transfer data.  (Reference 45 C.F.R. §171.103)

There are a variety of interrelated rules, including HIPAA, that are implicated, but key statutes and regulations include the 21st Century Cures Act, Section 4004, which amended the Public Health Service Act at 42 U.S.C. §300jj-52, authorizing OIG to investigate claims of information blocking and authorizing the Secretary of the Department of Health and Human Services (HHS) to impose Civil Monetary Penalties (CMPs) for information.  

ONC and CMS have also promulgated regulations, including the Information Blocking Rules, at 45 CFR Part 171.  Enforcement of the Information Blocking Rule began on Sept. 1, 2023, and enforcers include OIG.   There is also a variety of guidance available including the preamble issued with the Final Rule on Information Blocking at 88 Fed. Reg. 42820 (July 3, 2023) and a detailed FAQ page from ONC available online. 

The Information Blocking Rules are complex, but many hospitals are just looking for a few, bottom-line answers about effective dates, potential penalties, and whether patients must really get access to all lab and imaging results immediately – even if a physician would rather explain potentially devastating results first.

“Information Blocking” means a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of Electronic Health Information (EHI) when a healthcare provider knows that the practice is unreasonable and is likely to interfere with access, exchange, or use of the EHI.  (Reference 45 C.F.R. §171.103)

The rule applies to “Actors” which are not only healthcare providers, but also developers of certified health information technology, health information exchanges, and health information networks who are all prohibited from interfering with access to EHI unless one of the exceptions apply.   (Reference 45 C.F.R. §171.101, 102)

In a word, yes.  The Office of the National Coordinator for Health Information Technology (ONC) addressed this issue in its March 2021 FAQs in a response that explained:  “It would likely be considered an interference for purposes of information blocking if the healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or an order to personally inform the patient of the results before a patient can electronically access such results. (see also 85 FR 25842 specifying that such a practice does not qualify for the ‘Preventing Harm’ Exception).”   

While there is a “Preventing Harm” Exception, it is limited to physical harm, so it would not generally include emotional or mental anguish.  Even though a patient may suffer severe distress upon reviewing bad results before having a discussion with his/her physician, this type of harm does not qualify for the exception.  (Reference 45 C.F.R. §171.201)

An organizational policy that provided a blanket restriction would be problematic.  The “Preventing Harm” Exception is on a case-by-case basis, so a hospital should not set up a policy that, for a certain type of situation, lab results would be withheld, regardless of how emotionally devastating those results might be.  The ONC FAQs explain: “Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.”

The physicians should address this on a case-by-case basis, and one approach could be:  

• The physician could educate the individual patient receiving the test on the Information Blocking rules and explain that the lab/imaging report must be available to the patient immediately on the portal when the hospital receives it, at the same time the physician will receive it.  

• The physician can explain that the particular lab or radiology result can be confusing and that if the patient would prefer to meet with the doctor and discuss the results prior to seeing them that it is possible to withhold that and restrict it from the record until the patient has had a chance to talk with the physician about it.  

• If the patient agrees, the physician would complete an individualized, patient-specific exception form dated and signed by both the patient and the physician, to demonstrate compliance with the exception and avoid allegations of information blocking. 

Another instance where the exception form could prove useful is when a patient does not want information appearing on their portal, for example where a patient’s spouse has access to their portal, and the patient wants to maintain strict confidentiality of test results (such as for STDs).  

ONC and the Center for Medicaid and Medicare Services (CMS) released a proposed rule on Oct. 30, 2023 to establish “appropriate disincentives” for healthcare providers determined by Office of Inspector General (OIG) to have committed information blocking.  This proposed rule by ONC and CMS only contained proposed disincentives for healthcare providers that participate in the Medicare Promoting Interoperability or Medicare Shared Savings Program, or that serve a limited number of Medicare beneficiaries.  Under the proposed rule, ONC and CMS propose to use the existing Medicare Promoting Interoperability Program for the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and critical access hospitals (CAH).  Under the proposed rule, an eligible hospital or CAH would not be a meaningful EHR user in an EHR reporting period if OIG refers its determination that the eligible hospital or CAH committed information blocking during the calendar year of the reporting period.  A hospital would be unable to earn the three quarters of the annual market basket increase, and the CAH would have its payment reduced to 100% of reasonable costs, down from 10%. 

Yes.  Providers frequently have difficulty in getting information from Health Information Technology (HIT) vendors, particularly when changing or terminating IT vendors.  The Information Blocking rules also apply to health IT developers of certified HIT, health information exchanges, and health information networks.  Those entities violate the rule if they know or should know that their practice is likely to interfere with access, exchange, or use of electronic health information.  These rules, combined with Federal Trade Commission enforcement against anti-competitive conduct, may even be of assistance to hospitals faced with unreasonable charges from vendors to extract and transfer data.  (Reference 45 C.F.R. §171.103)

There are a variety of interrelated rules, including HIPAA, that are implicated, but key statutes and regulations include the 21st Century Cures Act, Section 4004, which amended the Public Health Service Act at 42 U.S.C. §300jj-52, authorizing OIG to investigate claims of information blocking and authorizing the Secretary of the Department of Health and Human Services (HHS) to impose Civil Monetary Penalties (CMPs) for information.  

ONC and CMS have also promulgated regulations, including the Information Blocking Rules, at 45 CFR Part 171.  Enforcement of the Information Blocking Rule began on Sept. 1, 2023, and enforcers include OIG.   There is also a variety of guidance available including the preamble issued with the Final Rule on Information Blocking at 88 Fed. Reg. 42820 (July 3, 2023) and a detailed FAQ page from ONC available online. 

The Information Blocking Rules are complex, but many hospitals are just looking for a few, bottom-line answers about effective dates, potential penalties, and whether patients must really get access to all lab and imaging results immediately – even if a physician would rather explain potentially devastating results first.

“Information Blocking” means a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of Electronic Health Information (EHI) when a healthcare provider knows that the practice is unreasonable and is likely to interfere with access, exchange, or use of the EHI.  (Reference 45 C.F.R. §171.103)

The rule applies to “Actors” which are not only healthcare providers, but also developers of certified health information technology, health information exchanges, and health information networks who are all prohibited from interfering with access to EHI unless one of the exceptions apply.   (Reference 45 C.F.R. §171.101, 102)

In a word, yes.  The Office of the National Coordinator for Health Information Technology (ONC) addressed this issue in its March 2021 FAQs in a response that explained:  “It would likely be considered an interference for purposes of information blocking if the healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or an order to personally inform the patient of the results before a patient can electronically access such results. (see also 85 FR 25842 specifying that such a practice does not qualify for the ‘Preventing Harm’ Exception).”   

While there is a “Preventing Harm” Exception, it is limited to physical harm, so it would not generally include emotional or mental anguish.  Even though a patient may suffer severe distress upon reviewing bad results before having a discussion with his/her physician, this type of harm does not qualify for the exception.  (Reference 45 C.F.R. §171.201)

An organizational policy that provided a blanket restriction would be problematic.  The “Preventing Harm” Exception is on a case-by-case basis, so a hospital should not set up a policy that, for a certain type of situation, lab results would be withheld, regardless of how emotionally devastating those results might be.  The ONC FAQs explain: “Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.”

The physicians should address this on a case-by-case basis, and one approach could be:  

• The physician could educate the individual patient receiving the test on the Information Blocking rules and explain that the lab/imaging report must be available to the patient immediately on the portal when the hospital receives it, at the same time the physician will receive it.  

• The physician can explain that the particular lab or radiology result can be confusing and that if the patient would prefer to meet with the doctor and discuss the results prior to seeing them that it is possible to withhold that and restrict it from the record until the patient has had a chance to talk with the physician about it.  

• If the patient agrees, the physician would complete an individualized, patient-specific exception form dated and signed by both the patient and the physician, to demonstrate compliance with the exception and avoid allegations of information blocking. 

Another instance where the exception form could prove useful is when a patient does not want information appearing on their portal, for example where a patient’s spouse has access to their portal, and the patient wants to maintain strict confidentiality of test results (such as for STDs).  

ONC and the Center for Medicaid and Medicare Services (CMS) released a proposed rule on Oct. 30, 2023 to establish “appropriate disincentives” for healthcare providers determined by Office of Inspector General (OIG) to have committed information blocking.  This proposed rule by ONC and CMS only contained proposed disincentives for healthcare providers that participate in the Medicare Promoting Interoperability or Medicare Shared Savings Program, or that serve a limited number of Medicare beneficiaries.  Under the proposed rule, ONC and CMS propose to use the existing Medicare Promoting Interoperability Program for the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and critical access hospitals (CAH).  Under the proposed rule, an eligible hospital or CAH would not be a meaningful EHR user in an EHR reporting period if OIG refers its determination that the eligible hospital or CAH committed information blocking during the calendar year of the reporting period.  A hospital would be unable to earn the three quarters of the annual market basket increase, and the CAH would have its payment reduced to 100% of reasonable costs, down from 10%. 

Yes.  Providers frequently have difficulty in getting information from Health Information Technology (HIT) vendors, particularly when changing or terminating IT vendors.  The Information Blocking rules also apply to health IT developers of certified HIT, health information exchanges, and health information networks.  Those entities violate the rule if they know or should know that their practice is likely to interfere with access, exchange, or use of electronic health information.  These rules, combined with Federal Trade Commission enforcement against anti-competitive conduct, may even be of assistance to hospitals faced with unreasonable charges from vendors to extract and transfer data.  (Reference 45 C.F.R. §171.103)

There are a variety of interrelated rules, including HIPAA, that are implicated, but key statutes and regulations include the 21st Century Cures Act, Section 4004, which amended the Public Health Service Act at 42 U.S.C. §300jj-52, authorizing OIG to investigate claims of information blocking and authorizing the Secretary of the Department of Health and Human Services (HHS) to impose Civil Monetary Penalties (CMPs) for information.  

ONC and CMS have also promulgated regulations, including the Information Blocking Rules, at 45 CFR Part 171.  Enforcement of the Information Blocking Rule began on Sept. 1, 2023, and enforcers include OIG.   There is also a variety of guidance available including the preamble issued with the Final Rule on Information Blocking at 88 Fed. Reg. 42820 (July 3, 2023) and a detailed FAQ page from ONC available online. 

The Information Blocking Rules are complex, but many hospitals are just looking for a few, bottom-line answers about effective dates, potential penalties, and whether patients must really get access to all lab and imaging results immediately – even if a physician would rather explain potentially devastating results first.

“Information Blocking” means a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of Electronic Health Information (EHI) when a healthcare provider knows that the practice is unreasonable and is likely to interfere with access, exchange, or use of the EHI.  (Reference 45 C.F.R. §171.103)

The rule applies to “Actors” which are not only healthcare providers, but also developers of certified health information technology, health information exchanges, and health information networks who are all prohibited from interfering with access to EHI unless one of the exceptions apply.   (Reference 45 C.F.R. §171.101, 102)

In a word, yes.  The Office of the National Coordinator for Health Information Technology (ONC) addressed this issue in its March 2021 FAQs in a response that explained:  “It would likely be considered an interference for purposes of information blocking if the healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or an order to personally inform the patient of the results before a patient can electronically access such results. (see also 85 FR 25842 specifying that such a practice does not qualify for the ‘Preventing Harm’ Exception).”   

While there is a “Preventing Harm” Exception, it is limited to physical harm, so it would not generally include emotional or mental anguish.  Even though a patient may suffer severe distress upon reviewing bad results before having a discussion with his/her physician, this type of harm does not qualify for the exception.  (Reference 45 C.F.R. §171.201)

An organizational policy that provided a blanket restriction would be problematic.  The “Preventing Harm” Exception is on a case-by-case basis, so a hospital should not set up a policy that, for a certain type of situation, lab results would be withheld, regardless of how emotionally devastating those results might be.  The ONC FAQs explain: “Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.”

The physicians should address this on a case-by-case basis, and one approach could be:  

• The physician could educate the individual patient receiving the test on the Information Blocking rules and explain that the lab/imaging report must be available to the patient immediately on the portal when the hospital receives it, at the same time the physician will receive it.  

• The physician can explain that the particular lab or radiology result can be confusing and that if the patient would prefer to meet with the doctor and discuss the results prior to seeing them that it is possible to withhold that and restrict it from the record until the patient has had a chance to talk with the physician about it.  

• If the patient agrees, the physician would complete an individualized, patient-specific exception form dated and signed by both the patient and the physician, to demonstrate compliance with the exception and avoid allegations of information blocking. 

Another instance where the exception form could prove useful is when a patient does not want information appearing on their portal, for example where a patient’s spouse has access to their portal, and the patient wants to maintain strict confidentiality of test results (such as for STDs).  

ONC and the Center for Medicaid and Medicare Services (CMS) released a proposed rule on Oct. 30, 2023 to establish “appropriate disincentives” for healthcare providers determined by Office of Inspector General (OIG) to have committed information blocking.  This proposed rule by ONC and CMS only contained proposed disincentives for healthcare providers that participate in the Medicare Promoting Interoperability or Medicare Shared Savings Program, or that serve a limited number of Medicare beneficiaries.  Under the proposed rule, ONC and CMS propose to use the existing Medicare Promoting Interoperability Program for the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and critical access hospitals (CAH).  Under the proposed rule, an eligible hospital or CAH would not be a meaningful EHR user in an EHR reporting period if OIG refers its determination that the eligible hospital or CAH committed information blocking during the calendar year of the reporting period.  A hospital would be unable to earn the three quarters of the annual market basket increase, and the CAH would have its payment reduced to 100% of reasonable costs, down from 10%. 

Yes.  Providers frequently have difficulty in getting information from Health Information Technology (HIT) vendors, particularly when changing or terminating IT vendors.  The Information Blocking rules also apply to health IT developers of certified HIT, health information exchanges, and health information networks.  Those entities violate the rule if they know or should know that their practice is likely to interfere with access, exchange, or use of electronic health information.  These rules, combined with Federal Trade Commission enforcement against anti-competitive conduct, may even be of assistance to hospitals faced with unreasonable charges from vendors to extract and transfer data.  (Reference 45 C.F.R. §171.103)

There are a variety of interrelated rules, including HIPAA, that are implicated, but key statutes and regulations include the 21st Century Cures Act, Section 4004, which amended the Public Health Service Act at 42 U.S.C. §300jj-52, authorizing OIG to investigate claims of information blocking and authorizing the Secretary of the Department of Health and Human Services (HHS) to impose Civil Monetary Penalties (CMPs) for information.  

ONC and CMS have also promulgated regulations, including the Information Blocking Rules, at 45 CFR Part 171.  Enforcement of the Information Blocking Rule began on Sept. 1, 2023, and enforcers include OIG.   There is also a variety of guidance available including the preamble issued with the Final Rule on Information Blocking at 88 Fed. Reg. 42820 (July 3, 2023) and a detailed FAQ page from ONC available online. 

The Information Blocking Rules are complex, but many hospitals are just looking for a few, bottom-line answers about effective dates, potential penalties, and whether patients must really get access to all lab and imaging results immediately – even if a physician would rather explain potentially devastating results first.

“Information Blocking” means a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of Electronic Health Information (EHI) when a healthcare provider knows that the practice is unreasonable and is likely to interfere with access, exchange, or use of the EHI.  (Reference 45 C.F.R. §171.103)

The rule applies to “Actors” which are not only healthcare providers, but also developers of certified health information technology, health information exchanges, and health information networks who are all prohibited from interfering with access to EHI unless one of the exceptions apply.   (Reference 45 C.F.R. §171.101, 102)

In a word, yes.  The Office of the National Coordinator for Health Information Technology (ONC) addressed this issue in its March 2021 FAQs in a response that explained:  “It would likely be considered an interference for purposes of information blocking if the healthcare provider established an organizational policy that, for example, imposed delays on the release of lab results for any period of time in order to allow an ordering clinician to review the results or an order to personally inform the patient of the results before a patient can electronically access such results. (see also 85 FR 25842 specifying that such a practice does not qualify for the ‘Preventing Harm’ Exception).”   

While there is a “Preventing Harm” Exception, it is limited to physical harm, so it would not generally include emotional or mental anguish.  Even though a patient may suffer severe distress upon reviewing bad results before having a discussion with his/her physician, this type of harm does not qualify for the exception.  (Reference 45 C.F.R. §171.201)

An organizational policy that provided a blanket restriction would be problematic.  The “Preventing Harm” Exception is on a case-by-case basis, so a hospital should not set up a policy that, for a certain type of situation, lab results would be withheld, regardless of how emotionally devastating those results might be.  The ONC FAQs explain: “Blanket delays that affect a broad array of routine results do not qualify for the Preventing Harm Exception. The Preventing Harm Exception is designed to cover only those practices that are no broader than necessary to reduce a risk of harm to the patient or another person.”

The physicians should address this on a case-by-case basis, and one approach could be:  

• The physician could educate the individual patient receiving the test on the Information Blocking rules and explain that the lab/imaging report must be available to the patient immediately on the portal when the hospital receives it, at the same time the physician will receive it.  

• The physician can explain that the particular lab or radiology result can be confusing and that if the patient would prefer to meet with the doctor and discuss the results prior to seeing them that it is possible to withhold that and restrict it from the record until the patient has had a chance to talk with the physician about it.  

• If the patient agrees, the physician would complete an individualized, patient-specific exception form dated and signed by both the patient and the physician, to demonstrate compliance with the exception and avoid allegations of information blocking. 

Another instance where the exception form could prove useful is when a patient does not want information appearing on their portal, for example where a patient’s spouse has access to their portal, and the patient wants to maintain strict confidentiality of test results (such as for STDs).  

ONC and the Center for Medicaid and Medicare Services (CMS) released a proposed rule on Oct. 30, 2023 to establish “appropriate disincentives” for healthcare providers determined by Office of Inspector General (OIG) to have committed information blocking.  This proposed rule by ONC and CMS only contained proposed disincentives for healthcare providers that participate in the Medicare Promoting Interoperability or Medicare Shared Savings Program, or that serve a limited number of Medicare beneficiaries.  Under the proposed rule, ONC and CMS propose to use the existing Medicare Promoting Interoperability Program for the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and critical access hospitals (CAH).  Under the proposed rule, an eligible hospital or CAH would not be a meaningful EHR user in an EHR reporting period if OIG refers its determination that the eligible hospital or CAH committed information blocking during the calendar year of the reporting period.  A hospital would be unable to earn the three quarters of the annual market basket increase, and the CAH would have its payment reduced to 100% of reasonable costs, down from 10%. 

Yes.  Providers frequently have difficulty in getting information from Health Information Technology (HIT) vendors, particularly when changing or terminating IT vendors.  The Information Blocking rules also apply to health IT developers of certified HIT, health information exchanges, and health information networks.  Those entities violate the rule if they know or should know that their practice is likely to interfere with access, exchange, or use of electronic health information.  These rules, combined with Federal Trade Commission enforcement against anti-competitive conduct, may even be of assistance to hospitals faced with unreasonable charges from vendors to extract and transfer data.  (Reference 45 C.F.R. §171.103)

There are a variety of interrelated rules, including HIPAA, that are implicated, but key statutes and regulations include the 21st Century Cures Act, Section 4004, which amended the Public Health Service Act at 42 U.S.C. §300jj-52, authorizing OIG to investigate claims of information blocking and authorizing the Secretary of the Department of Health and Human Services (HHS) to impose Civil Monetary Penalties (CMPs) for information.  

ONC and CMS have also promulgated regulations, including the Information Blocking Rules, at 45 CFR Part 171.  Enforcement of the Information Blocking Rule began on Sept. 1, 2023, and enforcers include OIG.   There is also a variety of guidance available including the preamble issued with the Final Rule on Information Blocking at 88 Fed. Reg. 42820 (July 3, 2023) and a detailed FAQ page from ONC available online.