Analysis of Ohioans for Medical Marijuana’s Proposed Ballot Initiative

By Jeff McCourt[1] and Aaron Mendelsohn[2]

Late last week the Ohio ballot board certified a constitutional amendment (the “Amendment”), proposed by Ohioans for Medical Marijuana (“OMM”),[3] to create a comprehensive regulatory program for the provision and sale of medical marijuana in Ohio (the “MMJ Program”).[4] This was the last step that OMM needed to launch its statewide signature gathering campaign, and the group now has until just after the 4th of July holiday to gather 305,591 signatures from voters across Ohio in order to put the Amendment on November’s general election ballot.

This following is a summary from a larger article that focuses on the key structural and economic components of the MMJ Program that, if passed, would be of most interest to prospective patients and market participants. As the campaign progresses, we will provide further detail on other aspects of the Amendment as well as its potential intersection with medical-cannabis legislation currently being considered in the Ohio Statehouse.

To download the complete article, click here.

Context and Path Forward.


Numerous polls over the past year suggest that Ohioans overwhelmingly support some form of patient access to medical cannabis, and that an initiative such as the Amendment would likely pass as long as it is not saddled with controversial provisions. Given the high-profile flameout of last year’s Issue 3 ballot initiative (which failed, largely because it allocated to Issue 3’s funders the only 10 cultivation licenses allowed by the proposal) and the legislative counterpunch of Issue 2 (which passed, largely because of public perception that it would prevent the cultivation oligopoly envisioned by Issue 3 and other similar ballot initiatives in the future), OMM made a curiously bold strategic choice by including in the Amendment a 15 license cap on the number of large cultivation facilities.

This single provision could hand the ballot board exactly the type of ‘hook’ it needs to label the Amendment as violative of Issue 2,[5] which would then require voters to approve not only the Amendment but also a separate ballot question that directly states the Amendment violates the Ohio Constitution because it grants a “monopoly, oligopoly, or cartel” not generally available to others.[6] While we have not seen polling on how this separate ballot question might impact the outcome of prior polls that asked for voters’ opinion on medical cannabis, logic and the result of last year’s vote on Issues 2 and 3 suggest that adding this Issue-2 question to the Amendment could generate a significantly different reaction from voters. Based on the questioning and commentary from ballot board members during the March 31, 2016 meeting at which it certified the Amendment, the fact that the Republican-led Ohio legislature is currently considering its own potentially competing medical cannabis legislation, and the overall political context of the Amendment during the general election, it seems likely that the conservative-controlled ballot board will seek to tack the Issue-2 question on to the Amendment if OMM gathers the signatures to put it on the ballot. While OMM would have solid arguments for challenging a decision by the ballot board to invoke ‘Issue 2 treatment,’ the conservative-leaning Ohio Supreme Court has exclusive jurisdiction over such challenges, and the language of Issue 2 grants the ballot board wide latitude to make this determination. It seems reasonably likely, therefore, that if OMM succeeds in putting the Amendment on the November ballot, that Ohio voters will also be asked to approve an Issue 2 question in addition to the Amendment.

Adding further complexity to the political landscape for the Amendment, members of both parties in the Ohio legislature are actively contemplating their own version of medical-cannabis legislation, and could move legislation quickly through committee to enactment by this summer (see our blog posts here, here and here). If the legislature is able to point to a well thought-out medical-cannabis system (the argument goes), it may be able to dissuade some voters from supporting a potentially broader market envisioned by the Amendment. Conversely, the legislature will also want to be careful in designing a program that won’t be rendered entirely useless if the Amendment passes.[7]

Even after factoring in the likelihood that OMM will have to pass both the Amendment and an ‘Issue 2’ approval and that the legislature will likely adopt a more measured medical-cannabis program in the interim months, the Amendment should still have a decent chance of passage if OMM can gather the signatures to put it on the ballot and support it with an aggressive public education campaign.

Key Takeaways.

For Ohio residents considering operating or investing in a medical cannabis business, the MMJ Program could provide access to a large pool of potential patients and present significant new-market business opportunities. Industry experts outside of Ohio with cannabis-consulting businesses should also find ample opportunities to collaborate with Ohio medical marijuana establishments (“MMEs”) licensed under the MMJ Program. The Amendment contains several provisions that could cause heartburn for some prospective market participants, however, such as entrepreneurs oriented to the ‘connoisseur’ or ‘craft’ end of the market as well as out-of-state businesses and investors looking for equity ownership.

If adopted by voters this November, the following elements of the MMJ Program should be of particular interest to potential market participants:

  • Speed to Open – The MMJ Program should be open for patients to register and for certain business to open by as early as August 1, 2017, with storefront dispensaries open to patients by late Q1 2018. A year-and-a-half from passage may not sound like warp speed to potential patients, but this would be a very quick startup period based on recent experience in other states. Arizona and Massachusetts, for example, took just over two years from constitutional amendment to licensure of their first dispensaries, while Nevada took over 15 years (though under different procedural circumstances).
  • Broad Patient Access – Comprehensive qualifying conditions are included, perhaps most notably “severe debilitating pain” and “severe nausea,” which should provide a fairly broad patient pool with access to medicinal cannabis. The Amendment does not go as far as states such as California and Massachusetts, which allow doctors to determine the debilitating conditions for which they deem medical cannabis appropriate. But the Amendment does allow the Medical Marijuana Control Division (the “Division”), created by the Amendment to administer the MMJ Program, to add additional qualifying conditions as it sees fit.
  •  Reciprocity – The Amendment also provides a form of “reciprocity” whereby nonresidents can purchase medical cannabis if they are registered in another state’s medical-cannabis program and their debilitating medical condition (as defined in Ohio) would allow them to qualify in Ohio. This could be an important feature for attracting residents of Ohio’s three most populous neighboring states (Michigan, Illinois and New York), each of which have legalized medical marijuana but have not yet allowed for meaningful patient access and/or functioning commercial-distribution systems.
  •  Homegrow Access – “Homegrow” will be permitted, with up to six plants per patient. Patients who cannot or don’t want to grow their own medical cannabis can specify a “designated caregiver” to grow up to the patient’s limit on their behalf. A designated caregiver can serve up to five specified patients (30 total plants). This type of patient-caregiver has served as the foundation of the medical-cannabis industry since California legalized medicinal use 20 years ago and is thought to be a source of innovation and evolution of ‘connoisseur’ applications within the ‘CannaTech’ space.
  •  Local Controls and Community Benefits – The MMJ Program includes both state and local licensing components that will allow for extensive participation (up to the point of total bans) by local governments and communities. The Amendment requires certain application-evaluation criteria that consider how the benefits of the MMJ Program are being shared among disadvantaged populations and whether dispensaries will provide reduced-cost medicine for low-income patients.
  •  Ohioans Only (for 2 years) – Ohio residents will have at least a two year head start (until January 2020) to build their brands and businesses before nonresidents can start investing in and controlling Ohio medical marijuana establishments (“MMEs”). Out-of-state investors looking to participate in the Ohio market as well as some in-state operators seeking outside investment are likely to have a different perspective on this provision.
  •  Federal Compliance – The Amendment will quickly create a “robust” regulatory regime that, assuming faithful implementation by the parties involved, should easily satisfy the ‘Cole Memo’ criteria for non-enforcement of the federal Controlled Substances Act by the Department of Justice and Drug Enforcement Agency. This is essential for creating an environment where patients and businesses can operate without fear of raids and asset seizures by law enforcement.

Conversely, the following provisions could present significant barriers to entry for would-be market participants, particularly local entrepreneurs looking to enter the ‘connoisseur’ or ‘craft’ end of the cultivation market as well as out-of-state businesses and investors.

  • Fees and Limits on Large Cultivations – The costs associated with large “Type 1” cultivations (“Type 1 Grows”) – up to $500,000 initial and annual fees – and the limited number of licenses available – up to 15 – could create substantial barriers to entry for smaller cultivators and allow the holders of these licenses to quickly capture most, if not all, of the potential cultivation market. The upfront and annual fees for all other types of MMEs, including the smaller “Type 2” cultivations (“Type 2 Grows”) are up to $5,000 initially and annually, which are relatively affordable compared to other states.
  •  Capital Requirements for All Cultivations – Aside from the upfront and annual licensure fees, perhaps the most restrictive aspect of the Amendment will be the substantial capital requirements that it establishes for cultivation applicants (both Type 1 and the smaller Type 2 Grows). Cultivation applicants will have to show that they have sufficient capital “available” to pay their license fees and to build and operate the grow for one year without revenue. In addition, this capital must have been “seasoned” (a term the Amendment does not define or explain) for 180-days prior to the application. While other states have used financial criteria to assist in determining the bona fides of applicants in a competitive licensure process, these provisions go beyond most other states and could create insurmountable financial hurdles for small businesses and entrepreneurs seeking to enter the market.
  •  Controlling Ownership Restrictions (and Ambiguities) – The Amendment provides ownership restrictions applicable to cultivations (Type 1 and Type 2 Grows) and testing facilities. The cultivation ownership restrictions are intended to limit cultivators to ownership of just one Type 1 or Type 2 Grow license, in an effort to preserve the intent behind the canopy-size limitations (25,000 sq. ft. for Type 1 Grows and 5,000 sq. ft. for Type 2 Grows). Testing facilities are required to not have common ownership with any other type of MME, in an effort to encourage independence from the customers they test. The “controlling person” definition, however, appears to be drafted in a way that could allow applicants to avoid these restrictions altogether through simple legal structuring. We trust the Division will be sufficiently motivated and legally empowered to address these potential ‘loop-holes’ in developing its detailed regulations for cultivation and testing facilities. These ambiguities are discussed in more detail below.

The combined impact of these three provisions could result in the ‘upstream’ cultivation market being dominated by the holders of the 15 Type 1 Grow licenses. This may feel like de-ja-vu for those critical of last year’s failed Issue 3 proposal. Some balancing factors in the Amendment may help to mitigate this impact, however, which we discuss in more detail below.

To download the complete article, click here.


 Disclaimer: As with all of our publications, we remind you that we are providing this analysis for general informational and educational purposes, to help advance a general understanding and discourse around cannabis law and regulated industries. This article does not provide legal advice or create an attorney-client relationship. Perhaps most importantly, please remember that the use, possession, distribution and sale of marijuana remain crimes under both federal law and the laws of Ohio. This publication does not, and should not in any way be construed to, assist anyone in violating applicable law.

[1] Jeff McCourt is an associate in our Corporate & Securities group in our Cleveland office, where he focuses on counseling emerging-growth companies and venture capital and private equity funds in a variety of business and finance matters. He can be reached at 216-363-4428 or

[2] Aaron Mendelsohn is an associate in Benesch’s 3iP group in our Cleveland office, where he focuses on technology transactions, data security and privacy compliance. He can be reached at 216-363-4635 or

[3] OMM is the state-level political action committee of the national cannabis-prohibition reform organization, Marijuana Policy Project (“MPP”) based out of Washington, DC. MPP has organized several successful campaigns over the past decade, including the 2012 campaign that legalized adult ‘recreational’ cannabis sales in Colorado and the 2008 Michigan ballot initiative, which legalized medicinal cannabis for Ohio’s northerly neighbors. According to OMM’s website, the campaign will need to raise $6 million by October 2016 to pass the Amendment, and that it plans to launch the signature drive on April 9th if it has raised $900,000 by mid-March.

[4] Ohio Attorney General Mike DeWine rejected OMM’s first submission of the Amendment on March 11, 2016, citing several inconsistencies between the summary and the language of the Amendment. OMM submitted its second submission of the Amendment on March 15, 2016 and the Attorney General certified this version of the Amendment on March 25, 2016.

[5] We use “Issue 2” in the colloquial sense to refer to the new provisions added to Article II, Section 1e of the Ohio Constitution, which in pertinent part provides that “the power of the initiative shall not be used to pass an amendment to this constitution that would grant or create a monopoly, oligopoly, or cartel, specify or determine a tax rate, or confer a commercial interest, commercial right, or commercial license to any person, nonpublic entity, or group of persons or nonpublic entities, or any combination thereof, however organized, that is not then available to other similarly situated persons or nonpublic entities” (emphasis added).

[6] Article II, Section 1e(B)(2)(a) of the Ohio Constitution states that, if the ballot board determines the Amendment violates the language cited in footnote 4, then the ballot shall first ask voters the question: “Shall the petitioner, in violation of division (B)(1) of Section 1e of Article II of the Ohio Constitution, be authorized to initiate a constitutional amendment that grants or creates a monopoly, oligopoly, or cartel, specifies or determines a tax rate, or confers a commercial interest, commercial right, or commercial license that is not available to other similarly situated persons?” Then the voters will be asked the second question of whether the Amendment should be passed.

[7] For instance, if the legislature’s program creates a new agency or utilizes an existing agency other than the Department of Health for administering its program, it will likely result in two overlapping administrative bodies responsible for regulating parallel markets. Also, if certain items like possession limits, doctor–patient relationship qualifications, prohibition on homegrow, taxation, etc. are threaded throughout the program, they could expose significant portions of the law to being struck down by courts as violative of broader constitutional rights provided by the Amendment.

Policy Perspectives Dominate The Discussion As The Medical Marijuana Task Force Looks To The Experts For Answers

By Ted Bibart, Legislative Analyst[1]

Another marathon evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”) was held on Thursday, March 10, 2016, as the Task Force heard testimony past 11 p.m. Chairman Kirk Schuring (R-Canton) was faced with the daunting task of managing a docket of fifteen witnesses and a packed house in the committee room.  Members of Benesch’s Regulated Industries Group (the “RIG”) were there to analyze the witness testimony and Task Force inquiries.

The evening’s expert testimony began with “A Perspective From Maryland” as Commissioner Deborah Miran, one of the fifteen members of the Maryland Medical Marijuana Commission, provided an in-depth discussion of the robust regulatory scheme crafted by the Maryland legislature. The Task Force members were clearly intrigued by the pertinent experience of Commissioner Miran. Having sat on the task force that in 2014 helped to overhaul Maryland’s prior (and largely unsuccessful) attempts to legalize medical cannabis, Commissioner Miran empathized with the enormity of the Task Force’s responsibilities in considering the question.  Her expertise, based on more than twenty years in the pharmaceutical industry, made for persuasive testimony.  Commissioner Miran took part in drafting and promulgating the regulations that govern medicinal cannabis in Maryland, which rely heavily on the regulatory schemes implemented in Arizona, Nevada, and Rhode Island.  Although Maryland’s medicinal market is not yet open to patients, industry experts have praised the comprehensiveness of its regulatory scheme, particularly with regard to product safety measures.  Commissioner Miran acknowledged that it had not been an easy road to legislation, and more wrinkles would have to be ironed out.  But she encouraged the Task Force to follow Maryland’s lead by not “reinventing the wheel” when crafting Ohio’s regulatory scheme.  Maryland identified the most effective and  robust elements of the various state approaches and innovated where necessary to serve the contours of Maryland’s market.  She thought a similar approach might be warranted for Ohio.

Another national expert, Dr. Malik Burnett, MD, MBA, a preventative medicine physician from Johns Hopkins University who trained in medicine and business administration at Duke University, advised the Task Force on the intersection of medicinal cannabis and public health.  His experience collaborating with policymakers and public health officials around the world provided a powerful medical perspective on some of the most complex regulatory questions that the Task Force members hope to answer.  State Representative Dan Ramos (D-Lorain), Jimmy Gould (Walnut Group/Responsible Ohio), and Dr. Brian Santin (Ohio State Medical Association) asked probing questions regarding physician autonomy, medical management, and patient access to a broad range of medical cannabis therapeutic options.  In all respects, Dr. Burnett advocated that any regulatory scheme must protect the sanctity of the doctor-patient relationship, and that patient access to medicinal cannabis should not be overly encumbered by the unnecessary, bureaucratic constraints, such as those that have crippled markets in Illinois and New York.  Linda Hondros, representing the Ohio Chamber of Commerce, presented a novel question, not yet posed by the Task Force, regarding information sharing by way of electronic medical records.  Dr. Burnett opined as to the possible benefits for patient care, as well as to the challenges such a system would present.  Dr. Burnett pointed to Maryland, and Commissioner Miran, as examples for the ability of legislators to come together with outside experts to make  state-based decisions that would rightly choose the appropriate approach in response to complicated policy considerations of this type.

Tom Downey, a national expert and prominent regulatory attorney in Denver, Colorado, echoed the sentiments of Commissioner Miran and Dr. Burnett, in highlighting the opportunity Ohio has to create a robust regulatory scheme ahead of industry implementation. Mr. Downey’s extensive experience as a Colorado Regulator, Director, and in drafting the original policies and procedures for Denver’s  legalized cannabis licensing structure, were extremely timely as the Task Force considers the best possible approaches to regulate medicinal cannabis.  He advocated a system that would not impose overly restrictive barriers to entry, but that would be intensive enough only to support sophisticated operators.  Key considerations included a regulatory scheme that was not initially under-funded, and that did not over-tax medicinal cannabis thereby fueling the black market.  Mr. Downey addressed the challenges and concerns resulting from the lack of financial institutions willing to serve marijuana related businesses, and encouraged legislators to seek the expertise of outside experts to investigate solutions.  Finally, Jimmy Gould asked Mr. Downey to consider the present state of Colorado after full implementation of legalized medicinal cannabis.  Mr. Downey assured the Task Force that the fear of the imagined “horror stories” that might result from legalization had proven unfounded in Colorado, instead the economy was booming, tourism was up, and the state budget was being balanced on the strength of $135 million in taxes and fees collected in 2015 alone.

The Task Force also continued to hear touching, anecdotal evidence from patients who had received exemplary benefits of medicinal cannabis therapies. Scarlett Leisure testified with fourteen month-old daughter Savannah in her arms to the incredible impact cannabis oil treatments have had on Savannah’s “catastrophic form of intractable epilepsy” resulting from a deletion mutation of one of her X-chromosomes.  Savannah was forced to endure a ketogenic diet and four medications at a time, and was still having at least 5 tonic-clonic seizures a day (all requiring the use of oxygen).   With no functioning solution in sight, Scarlett took Savannah to Colorado and started cannabis oil therapy on her own.  It was a calculated risk, as there was no medical supervision available in Ohio, but as a result Savannah has only had 8 seizures in the last 5 months (where under the traditional treatments she was receiving, she would have had approximately 750 in that time-span.)  In rebuttal to this anecdotal evidence, Dr. Michael Privitera, MD of the University of Cincinnati (also President of the American Epilepsy Society) cautioned that more testing was necessary to assure this type of cannabis therapy was safe and truly effective.  In Dr. Privitera’s opinion, legalizing medicinal cannabis therapies without the Food and Drug Administration’s (“FDA”) approval was premature.  Dr. Privitera had professed to limit the scope of his testimony to the sphere of epilepsy, but as it veered into other treatment modalities and broader generalizations were made about other fields of medicine, Dr. Santin was there to rein him in, particularly in the area of physician autonomy and patient access.  Finally, Jimmy Gould asked Dr. Privitera to reflect on the testimony and experience of Scarlett and Savannah Leisure. The doctor did acknowledge the effectiveness of medicinal cannabis, and clarified that in his opinion more testing should be done.

Lastly, Jöelle Khouzam of Bricker & Eckler testified on behalf of the Ohio Manufacturers’ Association (“OMA”). While Ms. Khouzam presented many open questions her client had regarding employment-related issues, she was unable to address many of the regulatory solutions other states had devised to satisfy the challenges to employers that these questions presented.  The Task Force looked to Ms. Khouzam for data substantiating the depth of concern underlying the issues she presented for consideration, and unfortunately none was presented in her testimony.  To help clarify her position, Dr. Santin, Chris Stock, State Representative and physician, Dr. Steve Huffman (R-Tipp City), and Rep. Ramos all drew analogies to present employer-related issues with opioid medication in hopes of elucidating the OMA’s stance and the manner in which medicinal cannabis would create different and greater concerns.  While the responses failed to demonstrate the uniqueness medicinal cannabis presents employers, it did highlight that there are existing answers in both existing, state regulatory schemes and case law.

[1] Ted Bibart, and the Benesch team, will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

Ohio’s Medical Marijuana Task Force Continues to Hear Testimony

By Jeff McCourt and Aaron Mendelsohn

Ohio’s Medical Marijuana Task Force (“Task Force”) continued to hear testimony on Thursday, February 25, 2016, as eleven individuals provided their thoughts related to medical cannabis in Ohio.  Most of the testimony was from proponents of medical cannabis, while one opponent, Captain Jeffrey Orr of the Trumbull County Sheriff’s Office, and one interested party, Dr. Anup Patel of Nationwide Children’s Hospital and The Ohio State University College of Medicine, offered alternative perspectives.

Dr. Patel’s testimony was of particular interest to the Task Force, as it lasted over forty-five minutes and included an open dialogue between Task Force members and Dr. Patel regarding his clinical studies using purified cannabidiol (CBD) compounds to treat severe epilepsy in children.  Dr.  Patel stated that the clinical studies he is leading at Nationwide Children’s Hospital are one of only two such studies sanctioned by the U.S. Food and Drug Administration (FDA) for CBD use to combat epilepsy in children.  Early indicators from his study suggest that CBD could reduce seizure frequency and has an adequate safety profile. Dr. Patel stressed that his research on the use of purified CBD extracts is different than that of “whole-plant” applications of medical cannabis, which he says have not received the same FDA review as CBD-only studies.  Dr. Patel’s research, along with others in the scientific community, seeks to determine the efficacy of purified CBD treatments (which contain none of the psychoactive ingredients in whole-plant medical cannabis), and Dr. Patel urged the Task Force to be cautious in crafting a legislative framework that legalizes anything without adequate scientific research to support its use.  Later testimony challenged some of Dr. Patel’s assertions, noting that the dearth of FDA sanctioned studies on whole-plant applications of medical cannabis is a direct result of the plant’s status as a Schedule I controlled substance under the Controlled Substances Act.

Of the evening’s proponent testimony, Dr. Michelle Price, a Dayton pharmacist, and Tamara Dietrich, of Scottsdale, Arizona’s Beacon Information Designs, provided particularly  interesting perspectives.  Dr. Price spoke at length about the historical use of medical cannabis in the US prior to its prohibition, the US Department of Health’s patent on medical cannabis, and some of the global research done on the endocannabinoid system.

Ms. Dietrich offered expertise regarding the need for a strong regulatory structure supported by information systems to track and maintain the entire medical cannabis system and infrastructure. Beacon Information Designs has done extensive research on this subject for the State of Arizona, and Ms. Dietrich provided the Task Force with much of this information, as well as offered her own opinions on which state regulatory structures have been successful.  For example, Ms. Dietrich spoke about her home state of Arizona’s lack of required testing, and the issues it has caused within the medical cannabis supply chain.   She also spoke about the perceived unfairness behind provisions of the Nevada medical cannabis law that only permit “homegrown” cannabis for patients who live twenty-five miles from a licensed dispensary.  Task Force member Lora Miller (Ohio Council of Retail Merchants) engaged Ms. Dietrich in dialogue regarding whether Ohio should have physician education requirements for recommending medical cannabis to patients, similar to laws in Maryland or New York.

Captain Orr’s opponent testimony began with him holding two bags of police-seized cannabis representing the two maximum weights for the two lowest misdemeanor criminal charges for possession of cannabis in Ohio.  The gesture grabbed the Task Force’s attention, and at times Captain Orr’s testimony took the tone of a cross examination as Task Force member Chris Stock (Markovits, Stock & DeMarco) probed Captain Orr regarding his proffered knowledge of an increased black market for cannabis in states that have recreation cannabis use.  After a repeated line of questioning by Mr. Stock, Captain Orr admitted to having never visited or raided dispensaries in any of these states but stated that he had worked with law enforcement joint-task forces in those states to bolster his testimony.

Of all the proponent testimonies, the most impactful may have come from the night’s last, as Patrick Rogers of Dayton limped to the podium to offer his heart wrenching story.  As a young cancer survivor, Mr. Rogers discussed how he traded being cancer free for a life of bone disease and other various painful afflictions that he said was caused by his cancer radiation treatments. He articulately spoke on how his personal use of medical cannabis has allowed him to walk relatively pain free, maintain a 40 hour a week job, and be a productive, tax paying citizen of Ohio.  Without access to medical cannabis, Mr. Rogers said he would be unable to move and provide for his family, and urged the Task Force to permit legal home grown medical cannabis.

The Task Force is off the week of February 29, but will resume with its final three sessions on Thursday, March 10 at 7 p.m., Thursday, March 17 at 3 p.m., and Thursday, March 31 at 3 p.m..

The Benesch team will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

New HIPAA Guidance on Patients’ Right to Records and Appropriate Fees for Copies

OCR issued new HIPAA guidance yesterday that reiterates patients’ right to access health information and clarifies appropriate fees providers can charge for copies.

In its clarification, OCR emphasized its view that the right of access is necessary to put the individual “in the driver’s seat” when it comes to their care, which OCR views as a key component of both health care reform and the movement toward a patient-centered health care system.

The HIPAA Privacy Rule has always provided individuals with the right to access and receive a copy of their health information from their providers.  However, this right has not always been understood by providers and patients.

In January 2016, OCR took an significant step toward removing those obstacles by issuing a comprehensive fact sheet and the first in a series of topical frequently asked questions (FAQs) addressing patients’ right to access their medical records.  Those FAQs explained the requirements providers must follow in sharing medical records with patients, including that they must do so in a timely manner and in a format that works for the patient.

OCR is providing this second set of FAQs to address additional issues, including the fees individuals may be charged for copies of their health information and the right of individuals to have their health information sent directly to a third party if they so choose.  The new FAQs clarify that individuals can be charged a reasonable, cost-based fee for the labor and supplies associated with making the copy, whether on paper or in electronic form.

Furthermore, the right to access includes the right to have the information sent directly to a third party, whether another health care provider, a friend or family member, researchers, or even a personal health record.

Like the Access fact sheet and FAQs released in January, this second guidance is aimed to assist providers in complying with the HIPAA Privacy Rule.  The complete set of materials – the Fact Sheet and both the first and second set of FAQs — may be found on OCR’s website at: